clinicaltrials.gov
Open in
urlscan Pro
2607:f220:41f:4290::20
Public Scan
URL:
https://clinicaltrials.gov/ct2/show/NCT05014672
Submission: On January 25 via manual from US — Scanned from DE
Submission: On January 25 via manual from US — Scanned from DE
Form analysis 1 forms found in the DOM
<form>
<div class="w3-center" style="font-size:large;font-weight:bold;padding:3ex 1.5em;">
<img src="/ct2/html/images/warning.png" alt="Maximum Saved Studies Reached" style="max-width:1.0rem;cursor:pointer;">
<b>Warning</b>
<div style="margin-top:1ex;margin-bottom:0.5ex;">You have reached the maximum number of saved studies (100).</div>
<div>Please remove one or more studies before adding more.</div>
</div>
<div class="w3-center" style="padding-bottom:1.5ex">
<input class="ct-searchButton" type="button" style="opacity:1.0;font-weight:bold;font-size:inherit;padding:1.1ex 1em;" onclick="$('#maxSavedStudies-popup').hide();" value="Close" title="Close this dialog">
</div>
</form>Text Content
We're building a better ClinicalTrials.gov. Check it out and tell us what you
think!
Hide glossary
GLOSSARY
Study record managers: refer to the Data Element Definitions if submitting
registration or results information.
Search for terms
* Accepts healthy volunteers
A type of eligibility criteria that indicates whether people who do not have
the condition/disease being studied can participate in that clinical study.
* Active comparator arm
An arm type in which a group of participants receives an
intervention/treatment considered to be effective (or active) by health care
providers.
* Adverse event
An unfavorable change in the health of a participant, including abnormal
laboratory findings, that happens during a clinical study or within a certain
amount of time after the study has ended. This change may or may not be
caused by the intervention/treatment being studied.
* Age or age group
A type of eligibility criteria that indicates the age a person must be to
participate in a clinical study. This may be indicated by a specific age or
the following age groups:
The age groups are:
* Child (birth-17)
* Adult (18-64)
* Older Adult (65+)
* All-cause mortality
A measure of all deaths, due to any cause, that occur during a clinical
study.
* Allocation
A method used to assign participants to an arm of a clinical study. The types
of allocation are randomized allocation and nonrandomized.
* Arm
A group or subgroup of participants in a clinical trial that receives a
specific intervention/treatment, or no intervention, according to the trial's
protocol.
* Arm type
A general description of the clinical trial arm. It identifies the role of
the intervention that participants receive. Types of arms include
experimental arm, active comparator arm, placebo comparator arm, sham
comparator arm, and no intervention arm.
* Baseline characteristics
Data collected at the beginning of a clinical study for all participants and
for each arm or comparison group. These data include demographics, such as
age, sex/gender, race and ethnicity, and study-specific measures (for
example, systolic blood pressure, prior antidepressant treatment).
* Canceled submission
Indicates that the study sponsor or investigator recalled a submission of
study results before quality control (QC) review took place. If the
submission was canceled on or after May 8, 2018, the date is shown. After
submission of study results, a study record cannot be modified until QC
review is completed, unless the submission is canceled.
* Certain agreements
Information required by the Food and Drug Administration Amendments Act of
2007. In general, this is a description of any agreement between the sponsor
of a clinical study and the principal investigator (PI) that does not allow
the PI to discuss the results of the study or publish the study results in a
scientific or academic journal after the study is completed.
* Certification
A sponsor or investigator may submit a certification to delay submission of
results information if they are applying for FDA approval of a new drug or
device, or new use of an already approved drug or device. A sponsor or
investigator who submits a certification can delay results submission up to 2
years after the certification/extension first submitted date, unless certain
events occur sooner. See Delay Results Type in the Results Data Element
definitions for more information about this certification.
* Certification/extension first posted
The date on which information about a certification to delay submission of
results or an extension request was first available on ClinicalTrials.gov.
ClinicalTrials.gov does not indicate whether the submission was a
certification or extension request. There is typically a delay between the
date the study sponsor or investigator submitted the certification or
extension request and the first posted date.
* Certification/extension first submitted
The date on which the study sponsor or investigator first submitted a
certification or an extension request to delay submission of results. A
sponsor or investigator who submits a certification can delay results
submission up to 2 years after this date, unless certain events occur sooner.
There is typically a delay between the date the certification or extension
request was submitted and the date the information is first available on
ClinicalTrials.gov (certification/extension first posted).
* Certification/extension first submitted that met QC criteria
The date on which the study sponsor or investigator first submitted a
certification or an extension request that is consistent with National
Library of Medicine (NLM) quality control (QC) review criteria. The sponsor
or investigator may need to revise and submit a certification or extension
request one or more times before NLM's QC review criteria are met. It is the
responsibility of the sponsor or investigator to ensure that the study record
is consistent with the NLM QC review criteria. Meeting QC criteria for an
extension request does not mean that the National Institutes of Health (NIH)
has determined that the request demonstrates good cause. The process for
review and granting of extension requests by the NIH is being developed.
* City and distance
In the search feature, the City field is used to find clinical studies with
locations in a specific city. The Distance field is used to find studies with
locations within the specified distance from a city in number of miles. For
example, if you choose Illinois as the state, identifying "Chicago" as the
city and "100 miles" as the distance will find all studies listing a location
within 100 miles of Chicago.
* Clinical study
A research study involving human volunteers (also called participants) that
is intended to add to medical knowledge. There are two types of clinical
studies: interventional studies (also called clinical trials) and
observational studies.
* Clinical trial
Another name for an interventional study.
* ClinicalTrials.gov identifier (NCT number)
The unique identification code given to each clinical study upon registration
at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for
example, NCT00000419).
* Collaborator
An organization other than the sponsor that provides support for a clinical
study. This support may include activities related to funding, design,
implementation, data analysis, or reporting.
* Condition/disease
The disease, disorder, syndrome, illness, or injury that is being studied. On
ClinicalTrials.gov, conditions may also include other health-related issues,
such as lifespan, quality of life, and health risks.
* Contact
The name and contact information for the person who can answer enrollment
questions for a clinical study. Each location where the study is being
conducted may also have a specific contact, who may be better able to answer
those questions.
* Country
In the search feature, the Country field is used to find clinical studies
with locations in a specific country. For example, if you choose the United
States, you can then narrow your search by selecting a state and identifying
a city and distance.
* Cross-over assignment
A type of intervention model describing a clinical trial in which groups of
participants receive two or more interventions in a specific order. For
example, two-by-two cross-over assignment involves two groups of
participants. One group receives drug A during the initial phase of the
trial, followed by drug B during a later phase. The other group receives drug
B during the initial phase, followed by drug A. So during the trial,
participants "cross over" to the other drug. All participants receive drug A
and drug B at some point during the trial but in a different order, depending
on the group to which they are assigned.
* Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific
integrity of a clinical trial. The DMC can recommend to the sponsor that the
trial be stopped if it is not effective, is harming participants, or is
unlikely to serve its scientific purpose. Members are chosen based on the
scientific skills and knowledge needed to monitor the particular trial. Also
called a data safety and monitoring board, or DSMB.
* Early Phase 1 (formerly listed as Phase 0)
A phase of research used to describe exploratory trials conducted before
traditional phase 1 trials to investigate how or whether a drug affects the
body. They involve very limited human exposure to the drug and have no
therapeutic or diagnostic goals (for example, screening studies, microdose
studies).
* Eligibility criteria
The key requirements that people who want to participate in a clinical study
must meet or the characteristics they must have. Eligibility criteria consist
of both inclusion criteria (which are required for a person to participate in
the study) and exclusion criteria (which prevent a person from
participating). Types of eligibility criteria include whether a study accepts
healthy volunteers, has age or age group requirements, or is limited by sex.
* Enrollment
The number of participants in a clinical study. The "estimated" enrollment is
the target number of participants that the researchers need for the study.
* Exclusion criteria
A type of eligibility criteria. These are reasons that a person is not
allowed to participate in a clinical study.
* Expanded access
A way for patients with serious diseases or conditions who cannot participate
in a clinical trial to gain access to a medical product that has not been
approved by the U.S. Food and Drug Administration (FDA). Also called
compassionate use. There are different expanded access types.
For more information, see FDA Expanded Access: Information for Patients.
* Expanded access status
* Available: Expanded access is currently available for this investigational
treatment, and patients who are not participants in the clinical study may
be able to gain access to the drug, biologic, or medical device being
studied.
* No longer available: Expanded access was available for this intervention
previously but is not currently available and will not be available in the
future.
* Temporarily not available: Expanded access is not currently available for
this intervention but is expected to be available in the future.
* Approved for marketing: The intervention has been approved by the U.S.
Food and Drug Administration for use by the public.
* Expanded access type
Describes the category of expanded access under U.S. Food and Drug
Administration (FDA) regulations. There are three types of expanded access:
* Individual Patients: Allows a single patient, with a serious disease or
condition who cannot participate in a clinical trial, access to a drug or
biological product that has not been approved by the FDA. This category
also includes access in an emergency situation.
* Intermediate-size Population: Allows more than one patient (but generally
fewer patients than through a Treatment IND/Protocol) access to a drug or
biological product that has not been approved by the FDA. This type of
expanded access is used when multiple patients with the same disease or
condition seek access to a specific drug or biological product that has
not been approved by the FDA.
* Treatment IND/Protocol: Allows a large, widespread population access to a
drug or biological product that has not been approved by the FDA. This
type of expanded access can only be provided if the product is already
being developed for marketing for the same use as the expanded access use.
* Experimental arm
An arm type in which a group of participants receives the
intervention/treatment that is the focus of the clinical trial.
* Extension request
In certain circumstances, a sponsor or investigator may request an extension
to delay the standard results submission deadline (generally one year after
the primary completion date). The request for an extension must demonstrate
good cause (for example, the need to preserve the scientific integrity of an
ongoing masked trial). All requests must be reviewed and granted by the
National Institutes of Health. This process for review and granting of
extension requests is being developed. See Delay Results Type in the Results
Data Element definitions for more information.
* Factorial assignment
A type of intervention model describing a clinical trial in which groups of
participants receive one of several combinations of interventions. For
example, two-by-two factorial assignment involves four groups of
participants. Each group receives one of the following pairs of
interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo
and drug B, or (4) a placebo and a placebo. So during the trial, all possible
combinations of the two drugs (A and B) and the placebos are given to
different groups of participants.
* FDAAA 801 Violations
A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug
Administration (FDA) has issued a Notice of Noncompliance to the responsible
party of an applicable clinical trial. A Notice of Noncompliance indicates
that the FDA has determined the responsible party was not in compliance with
the registration or results reporting requirements for the clinical trial
under the Food and Drug Administration Amendments Act of 2007, Section 801
(FDAAA 801).
The National Library of Medicine (NLM) is required by FDAAA 801 to add
information to a study record about any FDAAA 801 Violation. This information
is provided by the FDA. There are three categories of information that may be
included:
* Violation: Shown when the FDA issues a Notice of Noncompliance and posts
the Notice of Noncompliance on its designated webpage. There are three
types of violations:
* Failure to submit required clinical trial information
* Submission of false or misleading clinical trial information
* Failure to submit primary and secondary outcomes
* Correction: Shown when the FDA confirms that the responsible party has
updated the study record to correct the violation and posts the correction
notice on its designated webpage. Because of the time for FDA review and
processing, there may be a delay between the date when the study record
was updated and the addition of correction information to the FDAAA 801
Violation information.
* Penalty: Shown when the FDA imposes a penalty for the violation and posts
the penalty notice on its designated webpage.
* First posted
The date on which the study record was first available on ClinicalTrials.gov
after National Library of Medicine (NLM) quality control (QC) review has
concluded. There is typically a delay of a few days between the date the
study sponsor or investigator submitted the study record and the first posted
date.
* First submitted
The date on which the study sponsor or investigator first submitted a study
record to ClinicalTrials.gov. There is typically a delay of a few days
between the first submitted date and the record's availability on
ClinicalTrials.gov (the first posted date).
* First submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study
record that is consistent with National Library of Medicine (NLM) quality
control (QC) review criteria. The sponsor or investigator may need to revise
and submit a study record one or more times before NLM's QC review criteria
are met. It is the responsibility of the sponsor or investigator to ensure
that the study record is consistent with the NLM QC review criteria.
* Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801
of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand
ClinicalTrials.gov and create a clinical study results database. For more
information on FDAAA 801, see the History, Policies, and Laws page on this
site.
* Funder type
Describes the organization that provides funding or support for a clinical
study. This support may include activities related to funding, design,
implementation, data analysis, or reporting. Organizations listed as sponsors
and collaborators for a study are considered the funders of the study.
ClinicalTrials.gov refers to four types of funders:
* U.S. National Institutes of Health
* Other U.S. Federal agencies (for example, Food and Drug Administration,
Centers for Disease Control and Prevention, or U.S. Department of Veterans
Affairs)
* Industry (for example: pharmaceutical and device companies)
* All others (including individuals, universities, and community-based
organizations)
* Gender-based eligibility
A type of eligibility criteria that indicates whether eligibility to
participate in a clinical study is based a person's self-representation of
gender identity or gender (yes, no). Gender is distinct from sex.
* Group/cohort
A group or subgroup of participants in an observational study that is
assessed for biomedical or health outcomes.
* Human subjects protection review board
A group of people who review, approve, and monitor the clinical study's
protocol. Their role is to protect the rights and welfare of people
participating in a study (referred to as human research subjects), such as
reviewing the informed consent form. The group typically includes people with
varying backgrounds, including a community member, to make sure that research
activities conducted by an organization are completely and adequately
reviewed. Also called an institutional review board, or IRB, or an ethics
committee.
For more information, see Participating in Studies on this site.
* Inclusion criteria
A type of eligibility criteria. These are the reasons that a person is
allowed to participate in a clinical study.
* Informed consent
A process used by researchers to communicate to potential and enrolled
participants the risks and potential benefits of participating in a clinical
study.
For more information, see Participating in Studies on this site.
* Informed consent form (ICF)
The document used in the informed consent or process.
* Intervention model
The general design of the strategy for assigning interventions to
participants in a clinical study. Types of intervention models include:
single group assignment, parallel assignment, cross-over assignment, and
factorial assignment.
* Intervention/treatment
A process or action that is the focus of a clinical study. Interventions
include drugs, medical devices, procedures, vaccines, and other products that
are either investigational or already available. Interventions can also
include noninvasive approaches, such as education or modifying diet and
exercise.
* Interventional study (clinical trial)
A type of clinical study in which participants are assigned to groups that
receive one or more intervention/treatment (or no intervention) so that
researchers can evaluate the effects of the interventions on biomedical or
health-related outcomes. The assignments are determined by the study's
protocol. Participants may receive diagnostic, therapeutic, or other types of
interventions.
* Investigator
A researcher involved in a clinical study. Related terms include site
principal investigator, site sub-investigator, study chair, study director,
and study principal investigator.
* Last update posted
The most recent date on which changes to a study record were made available
on ClinicalTrials.gov. There may be a delay between when the changes were
submitted to ClinicalTrials.gov by the study's sponsor or investigator (the
last update submitted date) and the last update posted date.
* Last update submitted
The most recent date on which the study sponsor or investigator submitted
changes to a study record to ClinicalTrials.gov. There is typically a delay
of a few days between the last update submitted date and when the date
changes are posted on ClinicalTrials.gov (the last update posted date).
* Last update submitted that met QC criteria
The most recent date on which the study sponsor or investigator submitted
changes to a study record that are consistent with National Library of
Medicine (NLM) quality control (QC) review criteria. It is the responsibility
of the sponsor or investigator to ensure that the study record is consistent
with the NLM QC review criteria.
* Last verified
The most recent date on which the study sponsor or investigator confirmed the
information about a clinical study on ClinicalTrials.gov as accurate and
current. If a study with a recruitment status of recruiting; not yet
recruiting; or active, not recruiting has not been confirmed within the past
2 years, the study's recruitment status is shown as unknown.
* Listed location countries
Countries in which research facilities for a study are located. A country is
listed only once, even if there is more than one facility in the country. The
list includes all countries as of the last update submitted date; any country
for which all facilities were removed from the study record are listed under
removed location countries.
* Location terms
In the search feature, the Location terms field is used to narrow a search by
location-related terms other than Country, State, and City or distance. For
example, you may enter a specific facility name (such as National Institutes
of Health Clinical Center) or a part of a facility name (such as Veteran for
studies listing Veterans Hospital or Veteran Affairs in the facility name).
Note: Not all study records include this level of detail about locations.
* Masking
A clinical trial design strategy in which one or more parties involved in the
trial, such as the investigator or participants, do not know which
participants have been assigned which interventions. Types of masking
include: open label, single blind masking, and double-blind masking.
* NCT number
A unique identification code given to each clinical study record registered
on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for
example, NCT00000419). Also called the ClinicalTrials.gov identifier.
* No intervention arm
An arm type in which a group of participants does not receive any
intervention/treatment during the clinical trial.
* Observational study
A type of clinical study in which participants are identified as belonging to
study groups and are assessed for biomedical or health outcomes. Participants
may receive diagnostic, therapeutic, or other types of interventions, but the
investigator does not assign participants to a specific
interventions/treatment.
A patient registry is a type of observational study.
* Observational study model
The general design of the strategy for identifying and following up with
participants during an observational study. Types of observational study
models include cohort, case-control, case-only, case-cross-over, ecologic or
community studies, family-based, and other.
* Other adverse event
An adverse event that is not a serious adverse event, meaning that it does
not result in death, is not life-threatening, does not require inpatient
hospitalization or extend a current hospital stay, does not result in an
ongoing or significant incapacity or interfere substantially with normal life
functions, and does not cause a congenital anomaly or birth defect; it also
does not put the participant in danger and does not require medical or
surgical intervention to prevent one of the results listed above.
* Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a
clinical study by the study's sponsor, funders, or others. These numbers may
include unique identifiers from other trial registries and National
Institutes of Health grant numbers.
* Other terms
In the search feature, the Other terms field is used to narrow a search. For
example, you may enter the name of a drug or the NCT number of a clinical
study to limit the search to study records that contain these words.
* Outcome measure
For clinical trials, a planned measurement described in the protocol that is
used to determine the effect of an intervention/treatment on participants.
For observational studies, a measurement or observation that is used to
describe patterns of diseases or traits, or associations with exposures, risk
factors, or treatment. Types of outcome measures include primary outcome
measure and secondary outcome measure.
* Parallel assignment
A type of intervention model describing a clinical trial in which two or more
groups of participants receive different interventions. For example, a
two-arm parallel assignment involves two groups of participants. One group
receives drug A, and the other group receives drug B. So during the trial,
participants in one group receive drug A "in parallel" to participants in the
other group, who receive drug B.
* Participant flow
A summary of the progress of participants through each stage of a clinical
study, by study arm or group/cohort. This includes the number of participants
who started, completed, and dropped out of the study.
* Patient registry
A type of observational study that collects information about patients'
medical conditions and/or treatments to better understand how a condition or
treatment affects patients in the real world.
* Phase
The stage of a clinical trial studying a drug or biological product, based on
definitions developed by the U.S. Food and Drug Administration (FDA). The
phase is based on the study's objective, the number of participants, and
other characteristics. There are five phases: Early Phase 1 (formerly listed
as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used
to describe trials without FDA-defined phases, including trials of devices or
behavioral interventions.
* Phase 1
A phase of research to describe clinical trials that focus on the safety of a
drug. They are usually conducted with healthy volunteers, and the goal is to
determine the drug's most frequent and serious adverse events and, often, how
the drug is broken down and excreted by the body. These trials usually
involve a small number of participants.
* Phase 2
A phase of research to describe clinical trials that gather preliminary data
on whether a drug works in people who have a certain condition/disease (that
is, the drug's effectiveness). For example, participants receiving the drug
may be compared to similar participants receiving a different treatment,
usually an inactive substance (called a placebo) or a different drug. Safety
continues to be evaluated, and short-term adverse events are studied.
* Phase 3
A phase of research to describe clinical trials that gather more information
about a drug's safety and effectiveness by studying different populations and
different dosages and by using the drug in combination with other drugs.
These studies typically involve more participants.
* Phase 4
A phase of research to describe clinical trials occurring after FDA has
approved a drug for marketing. They include postmarket requirement and
commitment studies that are required of or agreed to by the study sponsor.
These trials gather additional information about a drug's safety, efficacy,
or optimal use.
* Phase Not Applicable
Describes trials without FDA-defined phases, including trials of devices or
behavioral interventions.
* Placebo
An inactive substance or treatment that looks the same as, and is given in
the same way as, an active drug or intervention/treatment being studied.
* Placebo comparator arm
An arm type in which a group of participants receives a placebo during a
clinical trial.
* Primary completion date
The date on which the last participant in a clinical study was examined or
received an intervention to collect final data for the primary outcome
measure. Whether the clinical study ended according to the protocol or was
terminated does not affect this date. For clinical studies with more than one
primary outcome measure with different completion dates, this term refers to
the date on which data collection is completed for all the primary outcome
measures. The "estimated" primary completion date is the date that the
researchers think will be the primary completion date for the study.
* Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most
important for evaluating the effect of an intervention/treatment. Most
clinical studies have one primary outcome measure, but some have more than
one.
* Primary purpose
The main reason for the clinical trial. The types of primary purpose are:
treatment, prevention, diagnostic, supportive care, screening, health
services research, basic science, and other.
* Principal investigator (PI)
The person who is responsible for the scientific and technical direction of
the entire clinical study.
* Protocol
The written description of a clinical study. It includes the study's
objectives, design, and methods. It may also include relevant scientific
background and statistical information.
* Quality control (QC) review
National Library of Medicine (NLM) staff perform a limited review of
submitted study records for apparent errors, deficiencies, or
inconsistencies. NLM staff identify potential major and advisory issues and
provide comments directly to the study sponsor or investigator. Major issues
identified in QC review must be addressed or corrected (see First submitted
that met QC criteria and Results first submitted that met QC criteria).
Advisory issues are suggestions to help improve the clarity of the record.
NLM staff do not verify the scientific validity or relevance of the submitted
information. The study sponsor or investigator is responsible for ensuring
that the studies follow all applicable laws and regulations.
* Randomized allocation
A type of allocation strategy in which participants are assigned to the arms
of a clinical trial by chance.
* Recruitment status
* Not yet recruiting: The study has not started recruiting participants.
* Recruiting: The study is currently recruiting participants.
* Enrolling by invitation: The study is selecting its participants from a
population, or group of people, decided on by the researchers in advance.
These studies are not open to everyone who meets the eligibility criteria
but only to people in that particular population, who are specifically
invited to participate.
* Active, not recruiting: The study is ongoing, and participants are
receiving an intervention or being examined, but potential participants
are not currently being recruited or enrolled.
* Suspended: The study has stopped early but may start again.
* Terminated: The study has stopped early and will not start again.
Participants are no longer being examined or treated.
* Completed: The study has ended normally, and participants are no longer
being examined or treated (that is, the last participant's last visit has
occurred).
* Withdrawn: The study stopped early, before enrolling its first
participant.
* Unknown: A study on ClinicalTrials.gov whose last known status was
recruiting; not yet recruiting; or active, not recruiting but that has
passed its completion date, and the status has not been last verified
within the past 2 years.
* Registration
The process of submitting and updating summary information about a clinical
study and its protocol, from its beginning to end, to a structured, public
Web-based study registry that is accessible to the public, such as
ClinicalTrials.gov.
* Removed location countries
Countries that appeared under listed location countries but were removed from
the study record by the sponsor or investigator.
* Reporting group
A grouping of participants in a clinical study that is used for summarizing
the data collected during the study. This grouping may be the same as or
different from a study arm or group.
* Responsible party
The person responsible for submitting information about a clinical study to
ClinicalTrials.gov and updating that information. Usually the study sponsor
or investigator.
* Results database
A structured online system, such as the ClinicalTrials.gov results database,
that provides the public with access to registration and summary results
information for completed or terminated clinical studies. A study with
results available on ClinicalTrials.gov is described as having the results
"posted."
Note: The ClinicalTrials.gov results database became available in September
2008. Older studies are unlikely to have results available in the database.
* Results delayed
Indicates that the sponsor or investigator submitted a certification or
extension request.
* Results first posted
The date on which summary results information was first available on
ClinicalTrials.gov after National Library of Medicine (NLM) quality control
(QC) review has concluded. There is typically a delay between the date the
study sponsor or investigator first submits summary results information (the
results first submitted date) and the results first posted date. Some results
information may be available at an earlier date if Results First Posted with
QC Comments.
* Results first posted with QC comments
The date on which summary results information was first available on
ClinicalTrials.gov with quality control review comments from the National
Library of Medicine (NLM) identifying major issues that must be addressed by
the sponsor or investigator. As of January 1, 2020, initial results
submissions for applicable clinical trials (ACTs) that do not meet quality
control review criteria will be publicly posted on ClinicalTrials.gov with
brief standardized major comments. Accordingly, the Results First Posted with
QC Comments date may be earlier than the Results First Posted date for an ACT
with summary results information that is not consistent with NLM quality
control review criteria.
* Results first submitted
The date on which the study sponsor or investigator first submits a study
record with summary results information. There is typically a delay between
the results first submitted date and when summary results information becomes
available on ClinicalTrials.gov (the results first posted date).
* Results first submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study
record with summary results information that is consistent with National
Library of Medicine (NLM) quality control (QC) review criteria. The sponsor
or investigator may need to revise and submit results information one or more
times before NLM's QC review criteria are met. It is the responsibility of
the sponsor or investigator to ensure that the study record is consistent
with the NLM QC review criteria.
* Results returned after quality control review
The date on which the National Library of Medicine provided quality control
(QC) review comments to the study sponsor or investigator. The sponsor or
investigator must address major issues identified in the review comments. If
there is a date listed for results returned after quality control review, but
there is not a subsequent date listed for results submitted to
ClinicalTrials.gov, this means that the submission is pending changes by the
sponsor or investigator.
* Results submitted to ClinicalTrials.gov
Indicates that the study sponsor or investigator has submitted summary
results information for a clinical study to ClinicalTrials.gov but the
quality control (QC) review process has not concluded.
The results submitted date indicates when the study sponsor or investigator
first submitted summary results information or submitted changes to summary
results information. Submissions with changes are typically in response to QC
review comments from the National Library of Medicine (NLM). If there is a
date listed for results submitted to ClinicalTrials.gov, but there is not a
subsequent date listed for results returned after quality control review,
this means that the submission is pending review by NLM.
* Secondary outcome measure
In a clinical study's protocol, a planned outcome measure that is not as
important as the primary outcome measure for evaluating the effect of an
intervention but is still of interest. Most clinical studies have more than
one secondary outcome measure.
* Serious adverse event
An adverse event that results in death, is life-threatening, requires
inpatient hospitalization or extends a current hospital stay, results in an
ongoing or significant incapacity or interferes substantially with normal
life functions, or causes a congenital anomaly or birth defect. Medical
events that do not result in death, are not life-threatening, or do not
require hospitalization may be considered serious adverse events if they put
the participant in danger or require medical or surgical intervention to
prevent one of the results listed above.
* Sex
A type of eligibility criteria that indicates the sex of people who may
participate in a clinical study (all, female, male). Sex is a person's
classification as female or male based on biological distinctions. Sex is
distinct from gender-based eligibility.
* Sham comparator arm
An arm type in which a group of participants receives a procedure or device
that appears to be the same as the actual procedure or device being studied
but does not contain active processes or components.
* Single group assignment
A type of intervention model describing a clinical trial in which all
participants receive the same intervention/treatment.
* Sort studies by
In Advanced Search, the Sort studies by option is used to change the order of
studies listed on the Search Results page. You can sort by Relevance or
Newest First:
* Relevance: Studies that best match your search terms appear higher in the
search results list. This is the default display for all searches.
* Newest First: Studies with the most recent First posted dates appear
higher in the search results list.
* Sponsor
The organization or person who initiates the study and who has authority and
control over the study.
* State
In the search feature, the State field is used to find clinical studies with
locations in a specific state within the United States. If you choose United
States in the Country field, you can search for studies with locations in a
specific state.
* Statistical analysis plan (SAP)
The written description of the statistical considerations and methods for
analyzing the data collected in the clinical study.
* Status
Indicates the current recruitment status or the expanded access status.
* Study completion date
The date on which the last participant in a clinical study was examined or
received an intervention/treatment to collect final data for the primary
outcome measures, secondary outcome measures, and adverse events (that is,
the last participant's last visit). The "estimated" study completion date is
the date that the researchers think will be the study completion date.
* Study design
The investigative methods and strategies used in the clinical study.
* Study documents
Refers to the type of documents that the study sponsor or principal
investigator may add to their study record. These include a study protocol,
statistical analysis plan, and informed consent form.
* Study IDs
Identifiers that are assigned to a clinical study by the study's sponsor,
funders, or others. They include unique identifiers from other trial study
registries and National Institutes of Health grant numbers. Note:
ClinicalTrials.gov assigns a unique identification code to each clinical
study registered on ClinicalTrials.gov. Also called the NCT number, the
format is "NCT" followed by an 8-digit number (for example, NCT00000419).
* Study record
An entry on ClinicalTrials.gov that contains a summary of a clinical study's
protocol information, including the recruitment status; eligibility criteria;
contact information; and, in some cases, summary results. Each study record
is assigned a ClinicalTrials.gov identifier, or NCT number.
* Study registry
A structured online system, such as ClinicalTrials.gov, that provides the
public with access to summary information about ongoing and completed
clinical studies.
* Study results
A study record that includes the summary results posted in the
ClinicalTrials.gov results database. Summary results information includes
participant flow, baseline characteristics, outcome measures, and adverse
events (including serious adverse events).
* Study start date
The actual date on which the first participant was enrolled in a clinical
study. The "estimated" study start date is the date that the researchers
think will be the study start date.
* Study type
Describes the nature of a clinical study. Study types include interventional
studies (also called clinical trials), observational studies (including
patient registries), and expanded access.
* Submitted date
The date on which the study sponsor or investigator submitted a study record
that is consistent with National Library of Medicine (NLM) quality control
(QC) review criteria.
* Title
The official title of a protocol used to identify a clinical study or a short
title written in language intended for the lay public.
* Title acronym
The acronym or initials used to identify a clinical study (not all studies
have one). For example, the title acronym for the Women's Health Initiative
is "WHI."
* U.S. Agency for Healthcare Research and Quality (AHRQ)
An agency within the U.S. Department of Health and Human Services. AHRQ's
mission is to produce evidence to make health care safer, higher quality,
more accessible, equitable, and affordable, and to work within the U.S.
Department of Health and Human Services and with other partners to make sure
that the evidence is understood and used.
* U.S. Food and Drug Administration (FDA)
An agency within the U.S. Department of Health and Human Services. The FDA is
responsible for protecting the public health by making sure that human and
veterinary drugs, vaccines and other biological products, medical devices,
the Nation's food supply, cosmetics, dietary supplements, and products that
give off radiation are safe, effective, and secure.
* Unknown
A type of recruitment status. It identifies a study on ClinicalTrials.gov
whose last known status was recruiting; not yet recruiting; or active, not
recruiting but that has passed its completion date, and the status has not
been verified within the past 2 years. Studies with an unknown status are
considered closed studies.
×
* Find Studies
* New Search
* Advanced Search
* See Studies by Topic
* See Studies on Map
* How to Search
* How to Use Search Results
* How to Find Results of Studies
* How to Read a Study Record
* About Studies
* Learn About Studies
* Other Sites About Studies
* Glossary of Common Site Terms
* Submit Studies
* Submit Studies to ClinicalTrials.gov PRS
* Why Should I Register and Submit Results?
* FDAAA 801 and the Final Rule
* How to Apply for a PRS Account
* How to Register Your Study
* How to Edit Your Study Record
* How to Submit Your Results
* Frequently Asked Questions
* Support Materials
* Training Materials
* Resources
* Selected Publications
* Clinical Alerts and Advisories
* RSS Feeds
* Trends, Charts, and Maps
* Downloading Content for Analysis
* About Site
* What's New
* ClinicalTrials.gov Background
* About the Results Database
* History, Policies, and Laws
* ClinicalTrials.gov Modernization
* Media/Press Resources
* Linking to This Site
* Terms and Conditions
* Disclaimer
* PRS Login
* Find Studies
* New Search
* Advanced Search
* See Studies by Topic
* See Studies on Map
* How to Search
* How to Use Search Results
* How to Find Results of Studies
* How to Read a Study Record
* About Studies
* Learn About Studies
* Other Sites About Studies
* Glossary of Common Site Terms
* Submit Studies
* Submit Studies to ClinicalTrials.gov PRS
* Why Should I Register and Submit Results?
* FDAAA 801 and the Final Rule
* How to Apply for a PRS Account
* How to Register Your Study
* How to Edit Your Study Record
* How to Submit Your Results
* Frequently Asked Questions
* Support Materials
* Training Materials
* Resources
* Selected Publications
* Clinical Alerts and Advisories
* RSS Feeds
* Trends, Charts, and Maps
* Downloading Content for Analysis
* About Site
* What's New
* ClinicalTrials.gov Background
* About the Results Database
* History, Policies, and Laws
* ClinicalTrials.gov Modernization
* Media/Press Resources
* Linking to This Site
* Terms and Conditions
* Disclaimer
* PRS Login
* Home
* Search Results
* Study Record Detail
Saved Studies (0)
Save this study
Warning
You have reached the maximum number of saved studies (100).
Please remove one or more studies before adding more.
A TRIAL OF SETANAXIB IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (PBC) AND
LIVER STIFFNESS (TRANSFORM)
The safety and scientific validity of this study is the responsibility of the
study sponsor and investigators. Listing a study does not mean it has been
evaluated by the U.S. Federal Government. Know the risks and potential benefits
of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05014672
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : December 19, 2022
See Contacts and Locations
View this study on Beta.ClinicalTrials.gov
Sponsor:
Calliditas Therapeutics Suisse SA
Information provided by (Responsible Party):
Calliditas Therapeutics AB ( Calliditas Therapeutics Suisse SA )
* Study Details
* Tabular View
* No Results Posted
* Disclaimer
* How to Read a Study Record
Study Description
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study is to evaluate the effect of setanaxib on
biochemical response at Week 52 in participants with primary biliary cholangitis
(PBC) and with elevated liver stiffness and intolerance or inadequate response
to ursodeoxycholic acid (UDCA).
Condition or disease Intervention/treatment Phase Primary Biliary Cholangitis
Liver Stiffness Drug: Setanaxib Drug: Placebo Phase 2 Phase 3
Study Design
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Layout table for study information Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 318 participants Allocation: Randomized Intervention
Model: Parallel Assignment Intervention Model Description: Placebo-controlled
1:1:1 in double blind treatment period with 1:1 reassignment to setanaxib in
extension period Masking: Double (Participant, Investigator) Primary Purpose:
Treatment Official Title: TRANSFORM: A 52-week, Randomized, Placebo-controlled,
Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension
Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver
Stiffness Actual Study Start Date : February 14, 2022 Estimated Primary
Completion Date : September 16, 2024 Estimated Study Completion Date : September
15, 2025
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics: North American Indian childhood cirrhosis
Genetic and Rare Diseases Information Center resources:
Primary Biliary Cholangitis
U.S. FDA Resources
Arms and Interventions
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Arm Intervention/treatment Experimental: Setanaxib 1200 mg/day
Participants will be administered setanaxib at a dose of 1200 mg/day for the
52-week double-blind treatment period and the 52-week extension period.
The interim analysis outcome will determine if the setanaxib dose level for
participants receiving 1200 mg/day will be escalated to 1600 mg/day for the
continued extension period.
Drug: Setanaxib
Oral tablets, 400mg per tablet
Experimental: Setanaxib 1600 mg/day
Participants will be administered setanaxib at a dose of 1600 mg/day for the
52-week double-blind treatment period and the 52-week extension period.
The interim analysis outcome will determine if the setanaxib dose level for
participants receiving 1600 mg/day will be reduced to 1200 mg/day for the
continued extension period.
Drug: Setanaxib
Oral tablets, 400mg per tablet
Placebo Comparator: Placebo
Participants will be administered a placebo for the 52-week double-blind
treatment period.
During the 52-week extension period, participants will switch from placebo to
setanaxib at a dose of either 1200 or 1600 mg/day depending on interim analysis
outcome.
Drug: Placebo
Oral tablets
Outcome Measures
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Primary Outcome Measures :
1. Proportion of Participants Achieving a Biochemical Response to Setanaxib
[ Time Frame: Baseline (Day 1) up to Week 52 ]
Biochemical response defined as alkaline phosphatase (ALP) reduction to
<1.67x upper limit of normal (ULN), ALP reduction ≥15% from baseline and
total bilirubin ≤1xULN.
Secondary Outcome Measures :
1. Change from Baseline in Fatigue [ Time Frame: Baseline (Day 1) and Week
52 ]
Assessed by the Patient-Reported Outcomes Measurement Information System
(PROMIS) short form-Fatigue 7b Daily.
2. Change from Screening in Liver Stiffness [ Time Frame: Screening (Day -28)
and Week 52 ]
Assessed by transient elastography (FibroScan®).
3. Change from Baseline in Primary Biliary Cirrhosis (PBC)-40 Fatigue Domain
[ Time Frame: Baseline (Day 1) and Week 52 ]
4. Change from Baseline in Patient's Global Impression of Severity (PGIS)
Fatigue [ Time Frame: Baseline (Day 1) and Week 52 ]
PGIS is measured on a 5-point scale, with 1 indicating symptoms are not
present and 5 indicating very severe symptoms.
5. Change from Baseline in Patient's Global Impression of Change (PGIC)
Fatigue [ Time Frame: Baseline (Day 1) and Week 52 ]
PGIC is measured on a 7-point scale, with 1 indicating symptoms are much
better and 7 indicating symptoms are much worse.
6. Change from Baseline in Worst Itch Numerical Scale Rating Scale (WI-NRS)
[ Time Frame: Baseline (Day 1) and Week 52 ]
WI-NRS is measured on a 11-point scale, with 0 indicating no itch and 10
indicating worst possible itch.
7. Change from Baseline in Primary Biliary Cirrhosis (PBC)-40 Itch Domain
[ Time Frame: Baseline (Day 1) and Week 52 ]
8. Change from Baseline in Patient's Global Impression of Severity (PGIS)
Pruritus [ Time Frame: Baseline (Day 1) and Week 52 ]
PGIS is measured on a 5-point scale, with 1 indicating symptoms are not
present and 5 indicating very severe symptoms.
9. Change from Baseline in Patient's Global Impression of Change (PGIC)
Pruritus [ Time Frame: Baseline (Day 1) and Week 52 ]
PGIC is measured on a 7-point scale, with 1 indicating symptoms are much
better and 7 indicating symptoms are much worse.
10. Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs)
[ Time Frame: Up to Week 52 ]
A TEAE is defined as any untoward medical occurrence in participants that
happens after study drug administration. Any clinically significant
abnormalities in vital signs, clinical laboratory tests (including
biochemistry, hematology, urinalysis, and thyroid function), or 12- lead
electrocardiogram (ECG) results will be recorded as Adverse Events (AEs).
AEs will be assessed using the Common Terminology Criteria for Adverse
Events (CTCAE); Version 4.03.
11. Proportion of Participants Who Experience Adverse Events of Special
Interest (AESIs) [ Time Frame: Up to Week 52 ]
AESIs include drug-induced liver injury (DILI), anemia and hypothyroidism.
Eligibility Criteria
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with
your doctor and family members or friends about deciding to join a study. To
learn more about this study, you or your doctor may contact the study research
staff using the contacts provided below. For general information, Learn About
Clinical Studies.
Layout table for eligibility information Ages Eligible for Study: 18 Years and
older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy
Volunteers: No
Criteria
Inclusion Criteria:
* Male or female participant aged ≥18 years, inclusive at the time of informed
consent.
* Willing and able to give written informed consent and to comply with the
requirements of the study.
* Definite or probable primary biliary cholangitis (PBC) diagnosis as
demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
* Documented history of elevated alkaline phsopatase (ALP) levels ≥1.67×upper
limit of normal (ULN) of the local reference range.
* Documented history of positive antimitochondrial antibodies (AMA) titer or
positive PBC-specific antibodies (anti-GP210 or anti-SP100 or antibodies
against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase
complex]).
* Historical liver biopsy consistent with PBC.
* Serum ALP ≥1.67×ULN at Screening.
* Liver stiffness measured by transient elastography (FibroScan®) of ≥8.8
kilopascals (kPa) and an interquartile range over median ratio (IQR/med) of
≤30% at Screening, are taken with the results expressed in kilopascals).
* Ursodeoxycholic acid (UDCA) prescriptional dose use for the past 6 months (at
a stable dose for >3 months prior to Screening) OR intolerant to UDCA (last
dose of UDCA >3 months prior to Screening). Intolerance to UDCA is defined as
participants unable to tolerate the full-labelled dose of UDCA in PBC (13-15
mg/kg) due to frequently reported gastrointestinal symptoms such as diarrhea
and abdominal pain.
* For participants receiving obeticholic acid (OCA), fenofibrate, or
bezafibrate treatment for at least 6 months and stable dose for >3 months
prior to Screening.
* For participants intolerant to OCA, OCA must have been discontinued >3 months
prior to Screening.
* For participants previously treated with bezafibrate or fenofibrate, and
these agents were discontinued prior to screening, they must have been
discontinued >3 months prior to Screening.
* Female participants of childbearing potential must use a highly effective
method of contraception to prevent pregnancy for ≥4 weeks before
Randomization and must agree to continue strict contraception up to 90 days
after the last dose of investigational medicinal product (IMP).
* For the purposes of this trial, women of childbearing potential are defined
as "Fertile, following menarche and until becoming postmenopausal unless
permanently sterile. Permanent sterilization methods include hysterectomy,
bilateral salpingectomy and bilateral oophorectomy."
* Postmenopausal state is defined as no menses for 12 months without an
alternative medical cause. In female participants who are not using
hormonal contraception or hormonal replacement therapy but with suspected
menopause and less than 12 months of amenorrhea, a high follicle
stimulating hormone (FSH) level in the postmenopausal range will be
required at Screening to confirm a postmenopausal state. Confirmation with
more than one FSH measurement is required.
* Highly effective contraception is defined as methods that can achieve a
failure rate of less than 1% per year when used consistently and correctly.
These methods are:
* Combined (estrogen and progestogen containing) hormonal contraception
associated with inhibition of ovulation (oral, intravaginal, or
transdermal)
* Progestogen-only hormonal contraception associated with inhibition of
ovulation (oral, injectable, or implantable)
* Intrauterine device
* Intrauterine hormone-releasing system
* Bilateral tubal occlusion
* Vasectomized partner
* Sexual abstinence (refraining from heterosexual intercourse during the
entire period of risk associate with the study treatments). The
reliability of sexual abstinence needs to be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of
the participant. Periodic abstinence (calendar, symptothermal,
post-ovulation methods), withdrawal (coitus interruptus), spermicides
only, and lactational amenorrhea method are not acceptable methods of
contraception. Female condom and male condom should not be used together.
* Female participants of childbearing potential must have a negative serum
pregnancy test at Screening and a negative urine pregnancy test at
Baseline/Randomization before dosing.
* Male participants with female partners of childbearing potential must be
willing to use a condom and require their partner to use a highly effective
contraceptive method. This requirement begins at the time of informed consent
and ends 90 days after receiving the last dose of IMP.
* Male participants must be willing not to donate sperm, and female study
participants must be willing not to donate eggs, from Baseline until 90 days
after the last dose of IMP.
Exclusion Criteria:
* A positive pregnancy test or breastfeeding for female participants.
* Any historical or current hepatic decompensation event defined as
variceal/portal hypertension bleed and/or hepatic encephalopathy, spontaneous
bacterial peritonitis, ascites requiring treatment, or liver transplantation
list inclusion.
* History of liver transplantation, current placement on a liver transplant
list or current model for end stage liver disease (MELD) score of ≥12 unless
the participant is on anticoagulant therapy, or a Child-Pugh Score of ≥6.
* Cirrhosis with complications, including history or presence of hepatocellular
carcinoma.
* Total bilirubin >2×ULN. In case of total bilirubin elevation >ULN the
Screening serum albumin must be within the reference range.
* Plasma alanine aminotransferase (ALT) >3×ULN and/or aspartate
aminotransferase (AST) >3×ULN.
* International normalized ratio (INR) >1.2 unless participant is on
anticoagulant therapy. One repeat blood sampling (with analysis by the
central laboratory) can be performed at the discretion of the Investigator at
Screening Visit 2 for participants who meet this exclusion criterion at
Screening Visit 1. If this exclusion criterion is not met at Screening Visit
2, the participant may be eligible for the study.
* Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2, as
calculated by the central laboratory using the chronic kidney
disease-epidemiology collaboration (CKD- EPI) equation.
* Thyroid-stimulating hormone >ULN at Screening. One repeat blood sampling
(with analysis by the central laboratory) can be performed at the discretion
of the Investigator at Screening Visit 2 for participants who meet this
exclusion criterion at Screening Visit 1. If this exclusion criterion is not
met at Screening Visit 2, the participant may be eligible for the study.
* Competing etiology for liver disease (eg, hepatitis C [unless effectively
cured of hepatitis C, with a sustained virologic response for at least 6
months prior to Screening], active hepatitis B [HBsAg positive], nonalcoholic
steatohepatitis [NASH], alcoholic liver disease, autoimmune hepatitis,
autoimmune hepatitis-PBC overlap syndrome, primary sclerosing cholangitis,
Gilbert's Syndrome).
* Medical conditions that could cause nonhepatic increases in ALP (eg, Paget's
disease).
* Known history of human immunodeficiency virus (HIV) infection.
* Surgery (eg, stomach bypass) or medical condition that might significantly
affect absorption of medicines (as judged by the Investigator).
* Positive urine drug screen (if not due to prescriptional use of a concomitant
medication, as confirmed by the Investigator) at Screening. Participants on
stable methadone or buprenorphine maintenance treatment for at least 6 months
prior to Screening Visit 1 may be included in the study. Medicinal cannabis
and cannabidiol products are not exclusionary and may be allowed if the
prescription and diagnosis are reviewed and approved by the Investigator.
* Participants receiving prohibited medications within 3 months of Screening
Visit 1.
* Treatment with any investigational agent within 12 weeks of Screening Visit 1
or 5 half-lives of the IMP (if known) (whichever is longer) or current
enrollment in an interventional clinical trial.
* Evidence of any of the following cardiac conduction abnormalities: A QTc
Fridericia interval >450 milliseconds for males or >470 milliseconds for
females, as calculated by the central reader. Participants with a second- or
third-degree atrioventricular block are to be excluded.
* For participants in the US, in participants treated with or for planned
treatment with a pacemaker, implanted cardioverter-difibrillator, or other
implanted electronic device, FibroScan® assessments will be prohibited.
* History of a malignancy within 5 years of Screening with the following
exceptions:
* Adequately treated carcinoma in situ of the cervix
* Adequately treated basal or squamous cell cancer or other localized
nonmelanoma skin cancer.
* The occurrence of any acute infection requiring systemic antibiotic therapy
within the 2 weeks prior to Screening Visit 1.
* A history of bone marrow disorder including aplastic anemia, or any current
marked anemia defined as hemoglobin <10.0 g/dL.
* Prior treatment with setanaxib or participation in a previous setanaxib
clinical trial.
* Unstable cardiovascular disease.
* Presence of any laboratory abnormality or condition that, in the opinion of
the Investigator, could interfere with or compromise a participant's
treatment, assessment, or compliance with the protocol and/or study
procedures.
* Any other condition which, in the opinion of the Investigator, constitutes a
risk or contraindication for the participation of the participant in the
study, or that could interfere with the study objectives, conduct, or
evaluation.
* Hypersensitivity or intolerance to setanaxib or to any of its excipients or
placebo compounds.
Contacts and Locations
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study
research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number):
NCT05014672
Contacts
Layout table for location contacts Contact: Stefan Carlsson +46 8 411 3005
Stefan.carlsson@calliditas.com
Locations
Show 94 study locations Hide 94 study locations
Layout table for location information United States, California Cedars-Sinai
Medical Center Recruiting Los Angeles, California, United States, 90048
California Liver Research Institute Recruiting Pasadena, California, United
States, 91105 University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817 United States, Florida
Gastroenterology Associates - Crystal River Recruiting Inverness, Florida,
United States, 34452 University of Miami Leonard M. Miller School of Medicine
Recruiting Miami, Florida, United States, 33136 Advanced Research Institute,
Inc. Recruiting Orlando, Florida, United States, 32825 United States, Illinois
Northwestern University Recruiting Evanston, Illinois, United States, 60611
United States, Kansas Kansas Medical Clinic - Gastroenterology Recruiting
Topeka, Kansas, United States, 66606 United States, Louisiana Tulane Medical
Center Recruiting New Orleans, Louisiana, United States, 70112 United States,
Michigan A. Alfred Taubman Health Care Center Recruiting Ann Arbor, Michigan,
United States, 48109 Henry Ford Hospital Recruiting Detroit, Michigan, United
States, 48202 United States, Mississippi Summit - Southern Therapy and Advanced
Research Recruiting Jackson, Mississippi, United States, 39216 United States,
New York Northwell Health Withdrawn Manhasset, New York, United States, 11030
New York University Hepatology Associates Recruiting New York, New York, United
States, 10016 Icahn School of Medicine at Mount Sinai Recruiting New York, New
York, United States, 10029 United States, North Carolina Wake Forest University
Baptist Medical Center Recruiting Winston-Salem, North Carolina, United States,
27157 United States, Ohio University of Cincinnati Recruiting Cincinnati, Ohio,
United States, 45267-0595 United States, Pennsylvania Einstein Medical Center
Recruiting Philadelphia, Pennsylvania, United States, 19141 United States, South
Dakota Rapid City Medical Center Recruiting Rapid City, South Dakota, United
States, 57701 United States, Tennessee Vanderbilt Digestive Disease Center
Recruiting Nashville, Tennessee, United States, 37232 United States, Texas Liver
Specialists of Texas Recruiting Houston, Texas, United States, 77030 Pioneer
Research Solutions Recruiting Houston, Texas, United States, 77099 United
States, Utah University of Utah Hospital Recruiting Salt Lake City, Utah, United
States, 84132 Australia, New South Wales Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050 John Hunter Hospital Recruiting New
Lambton Heights, New South Wales, Australia, 2305 Australia, Queensland Mater
Misericordiae - Hospital Brisbane Recruiting South Brisbane, Queensland,
Australia, 4101 Australia, South Australia Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042 Australia, Victoria Eastern
Health - Australia Recruiting Box Hill, Victoria, Australia, 3128 Monash Medical
Centre Recruiting Clayton, Victoria, Australia, 3168 Australia, Western
Australia Fiona Stanley Hospital Recruiting Murdoch, Western Australia,
Australia, 6150 Australia Nepean Hospital Recruiting Kingswood, Australia, 2747
Liverpool Hospital Recruiting Liverpool, Australia, 2170 The Alfred Hospital
Recruiting Melbourne, Australia, 3004 Austria Klinikum Wels-Grieskirchen
Recruiting Wels, Oberösterreich, Austria, 4600 Universitaetsklinikum Graz -
Universitätsklinik für Innere Medizin Recruiting Graz, Styria, Austria, 8036
Medizinische Universität Innsbruck Recruiting Innsbruck, Tyrol, Austria, 6020
Belgium Hôpital Erasme Recruiting Bruxelles, Brussels, Belgium, 1070 Centre
Hospitalier Universitaire Brugmann - Site Victor Horta Recruiting Laeken,
Brussels, Belgium, 1020 Canada, Alberta University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6 Canada, Ontario Centricity Research (LMC Manna
Research) - London Recruiting London, Ontario, Canada, N6A 2C2 Office Of
Stephane M. Gauthier Recruiting North Bay, Ontario, Canada, P1B 2H3 University
Health Network Recruiting Toronto, Ontario, Canada, M5G 2C4 Toronto Liver Center
Recruiting Toronto, Ontario, Canada, M6H 3M1 Canada, Quebec Centre Hospitalier
de l'Université de Montréal (CHUM) Recruiting Montréal, Quebec, Canada, H2X 3J4
Canada William Osler Health System - Brampton Civic Hospital Recruiting
Brampton, Canada, L6R 3J7 Czechia Ústřední Vojenská Nemocnice Praha Recruiting
Praha, Prague, Czechia, 169 02 Hepato-Gastroenterologie HK Recruiting Hradec
Králové, Czechia, 500 12 France Hopital Dupuytren Recruiting Limoges, Limousin,
France, 87042 Hôpitaux de Brabois Recruiting Vandœuvre-lès-Nancy, Lorraine,
France, 54511 Hôpital Rangueil Recruiting Toulouse, Occitanie, France, 31059
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud Recruiting Amiens,
Picardie, France, 80054 Hôpital de la Croix Rousse Recruiting Lyon, Rhone-alpes,
France, 69317 Hôpital Claude Huriez Recruiting Lille, France, 59037 Hôpital
Saint Joseph Marseille Recruiting Marseille, France, 13008 Hôpital l'Archet
Recruiting Nice, France, 06202 Hôpital Saint-Antoine Recruiting Paris, France,
75012 Germany Klinikum rechts der Isar der Technischen Universität München
Recruiting Munich, Bayern, Germany, 81675 Universitätsklinikum Frankfurt
Recruiting Frankfurt, Hessen, Germany, 60590 St. Josefs-Hospital Wiesbaden
Recruiting Wiesbaden, Hessen, Germany, 65189 Eugastro Recruiting Leipzig,
Sachsen, Germany, 04103 Universitätsklinikum des Saarlandes Recruiting Homburg,
Germany, 66421 Greece University General Hospital of Heraklion (PAGNI)
Recruiting Heraklion, Greece, 71110 University General Hospital of Larissa
Recruiting Larissa, Greece, 41110 Hungary Semmelweis Egyetem - I. Sz. Sebészeti
és Intervenciós Gasztroenterológiai Klinika Recruiting Budapest, Hungary, 1082
Israel Carmel Medical Center Recruiting Haifa, Haifa District, Israel, 3436212
Rabin Medical Center - Beilinson Hospital Recruiting Petah Tikva, Tel Aviv,
Israel, 4941492 Hadassah University Hospital Ein Kerem Recruiting Jerusalem,
Israel, 9112001 Tel Aviv Sourasky Medical Center Recruiting Tel Aviv, Israel,
64239 Italy Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Recruiting Novara, Italy, 28100 New Zealand Auckland City Hospital Recruiting
Grafton, Auckland, New Zealand, 1023 Wellington Regional Hospital Recruiting
Crofton Downs, Wellington, New Zealand, 6021 Dunedin Hospital Recruiting
Dunedin, New Zealand, 9016 Waikato Hospital Recruiting Hamilton, New Zealand,
3240 Poland Szpital Specjalistyczny Nr 1 w Bytomiu Recruiting Bytom, Poland,
41-902 ID Clinic Recruiting Myslowice, Poland, 41-400 Centrum Badań Klinicznych
Piotr Napora Lekarze Sp. p. Recruiting Wrocław, Poland, 51-162 Spain Hospital
Germans Trias i Pujol Recruiting Badalona, Barcelona, Spain, 08916 Hospital de
Sabadell Recruiting Sabadell, Barcelona, Spain, 08208 Hospital General
Universitari d'Alicante Recruiting Alicante, Spain, 03010 Complejo Hospitalario
Torrecárdenas Recruiting Almería, Spain, 04009 Hospital del Mar - Parc de Salut
Mar Recruiting Barcelona, Spain, 08003 Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036 Hospital Universitario Reina Sofía Recruiting Córdoba,
Spain, 14004 Hospital General Universitario Gregorio Marañón Recruiting Madrid,
Spain, 28007 Hospital Universitario La Paz Recruiting Madrid, Spain, 28046
Hospital Clínico Universitario de Santiago Recruiting Santiago, Spain, 15706
Hospital Universitario Virgen del Rocío Recruiting Sevilla, Spain, 41011
Consorci Hospital General Universitari de València Recruiting València, Spain,
46014 Sweden Akademiska Sjukhuset - Uppsala Recruiting Uppsala, Sweden, 751 85
Switzerland Fondazione Epatocentro Ticino Recruiting Lugano, Ticino,
Switzerland, 6900 Kantonsspital Sankt Gallen Recruiting Sankt Gallen,
Switzerland, 9007 United Kingdom King's College Hospital NHS Foundation Trust
Recruiting London, England, United Kingdom, SE5 9RS Nottingham University
Hospitals NHS Trust Recruiting Nottingham, England, United Kingdom, NG7 2UH NHS
Greater Glasgow and Clyde Recruiting Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
Calliditas Therapeutics Suisse SA
More Information
Go to
Top of Page Study Description Study Design Arms and Interventions Outcome
Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information Responsible Party: Calliditas
Therapeutics Suisse SA ClinicalTrials.gov Identifier: NCT05014672 History of
Changes Other Study ID Numbers: GSN000350
2021-001810-13 ( EudraCT Number )
First Posted: August 20, 2021 Key Record Dates Last Update Posted: December
19, 2022 Last Verified: December 2022 Individual Participant Data (IPD) Sharing
Statement: Plan to Share IPD: No
Layout table for additional information Studies a U.S. FDA-regulated Drug
Product: Yes Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Calliditas Therapeutics AB ( Calliditas Therapeutics Suisse
SA ):
Setanaxib
Primary Biliary Cholangitis
Elevated Liver Stiffness
Additional relevant MeSH terms:
Layout table for MeSH terms Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis
Fibrosis
Pathologic Processes
To Top
* For Patients and Families
* For Researchers
* For Study Record Managers
* Home
* RSS Feeds
* Site Map
* Terms and Conditions
* Disclaimer
* Customer Support
* Copyright
* Privacy
* Accessibility
* Viewers and Players
* Freedom of Information Act
* USA.gov
* HHS Vulnerability Disclosure
* U.S. National Library of Medicine
* U.S. National Institutes of Health
* U.S. Department of Health and Human Services