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GLOSSARY

Study record managers: refer to the Data Element Definitions if submitting
registration or results information.

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 * 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 Clinical Trial Reporting Requirements 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 on a person's self-representation of
   gender identity. Gender identity refers to a person's own sense of gender,
   which may or may not be the same as their biological 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 Who can join clinical research? 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 Who can join clinical research? 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
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Recruiting


STUDY ON EFFICACY AND SAFETY OF GIVINOSTAT VERSUS HYDROXYUREA IN PATIENTS WITH
POLYCYTHEMIA VERA (GIV-IN PV)

ClinicalTrials.gov ID NCT06093672
Sponsor Italfarmaco
Information provided by Italfarmaco (Responsible Party)
Last Update Posted 2024-12-06
Expand all content Collapse all content

Study DetailsResearcher ViewNo Results PostedRecord History

On this page
Study Overview
Contacts and Locations
Participation Criteria
Study Plan
Collaborators and Investigators
Study Record Dates
More Information


STUDY OVERVIEW

Brief Summary
The goal of this clinical trial is to compare the efficacy and safety of
givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera
patients.
Official Title
Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and
Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk
Polycythemia Vera Patients: the GIV-IN PV TRIAL
Conditions
Polycythemia Vera
Intervention / Treatment
 * Drug: Givinostat
 * Drug: Hydroxyurea
   

 * Drug: Givinostat

 * Drug: Hydroxyurea

Other Study ID Numbers
 * DSC/08/2357/32
   
   

Study Start (Actual)
2024-03-26
Primary Completion (Estimated)
2026-07
Study Completion (Estimated)
2026-07
Enrollment (Estimated)
220
Study Type
Interventional
Phase
Phase 3

RESOURCE LINKS PROVIDED BY THE NATIONAL LIBRARY OF MEDICINE

MedlinePlus Genetics(https://medlineplus.gov/genetics/) related topics: 
Polycythemia vera(https://medlineplus.gov/genetics/condition/polycythemia-vera) 
Genetic and Rare Diseases Information
Center(https://rarediseases.info.nih.gov/gard) resources:  Polycythemia
Vera(https://rarediseases.info.nih.gov/diseases/7422/polycythemia-vera)  Chronic
Myeloproliferative
Disorders(https://rarediseases.info.nih.gov/diseases/9319/chronic-myeloproliferative-disorders) 
Drug Information(https://dailymed.nlm.nih.gov/dailymed/) available for: 
Hydroxyurea(https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=human&query=Hydroxyurea) 
FDA Drug and Device Resources(https://www.clinicaltrials.gov/fda-links)


CONTACTS AND LOCATIONS

This section provides contact details for people who can answer questions about
joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a
Study
Record(https://www.clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: Maurizio Caserini

Phone Number: +39 02 6443 1

Email: patientadvocacy@italfarmacogroup.com

This study has 76 locations
United States
Alabama Locations
Birmingham, Alabama, United States, 35294-0001

Not yet recruiting

University of Alabama at Birmingham

California Locations
Redlands, California, United States, 92373

Recruiting

Emad Ibrahim, MD, Inc

New York Locations
New York, New York, United States, 10029

Not yet recruiting

Icahn School of Medicine at Mount Sinai

Ohio Locations
Cleveland, Ohio, United States, 44195

Recruiting

The Cleveland Clinic Foundation

Texas Locations
Houston, Texas, United States, 77030

Not yet recruiting

MD Anderson Cancer Center

Utah Locations
Salt Lake City, Utah, United States, 84112

Recruiting

University of Utah - Huntsman Cancer Institute - PPDS

Washington Locations
Seattle, Washington, United States, 98108-1532

Not yet recruiting

VA Puget Sound Health Care System - NAVREF - PPDS

Austria
Niederösterreich Locations
Wiener Neustadt, Niederösterreich, Austria, 2700

Not yet recruiting

Landesklinikum Wiener Neustadt

Oberösterreich Locations
Linz, Oberösterreich, Austria, 4020

Not yet recruiting

Ordensklinikum Linz GmbH Elisabethinen

Wels, Oberösterreich, Austria, 4600

Recruiting

Klinikum Wels-Grieskirchen GmbH

Wien Locations
Vienna, Wien, Austria, 1090

Not yet recruiting

Medizinische Universitat Wien (Medical University of Vienna)

Bulgaria
Plovdiv, Bulgaria, 4001

Recruiting

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Stara Zagora, Bulgaria, 6003

Recruiting

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan
Kirkovich AD

Sofia-Grad Locations
Sofia, Sofia-Grad, Bulgaria, 1407

Recruiting

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

Croatia
Rijeka, Croatia, 51000

Not yet recruiting

Clinical Hospital Center Rijeka

Šibenik, Croatia, 22000

Not yet recruiting

General Hospital Sibenik

Grad Zagreb Locations
Zagreb, Grad Zagreb, Croatia, 10000

Not yet recruiting

Clinical Hospital Center Zagreb

Zagreb, Grad Zagreb, Croatia, 10000

Not yet recruiting

Clinical Hospital Dubrava

France
Paris, France, 75010

Not yet recruiting

Hôpital Saint Louis

Aisne Locations
Saint-Quentin, Aisne, France, 2100

Not yet recruiting

Centre Hospitalier de Saint-Quentin

Alpes-Maritimes Locations
Nice, Alpes-Maritimes, France, 6202

Not yet recruiting

CHU de Nice

Aube Locations
Troyes, Aube, France, 10000

Recruiting

Centre Hospitalier de Troyes

Indre-et-Loire Locations
Tours, Indre-et-Loire, France, 37044

Not yet recruiting

Hôpital Bretonneau

Loire-Atlantique Locations
Nantes, Loire-Atlantique, France, 44000

Recruiting

CHU Nantes

Maine-et-Loire Locations
Angers, Maine-et-Loire, France, 49000

Recruiting

CHU Angers

Somme Locations
Amiens, Somme, France, 80054

Not yet recruiting

CHU Amiens Hôpital Sud

Île-de-France Locations
Argenteuil, Île-de-France, France, 95107

Not yet recruiting

Hopital d'Argenteuil

Germany
Hamburg, Germany, 22081

Not yet recruiting

OncoResearch Lerchenfeld GmbH

Baden-Württemberg Locations
Mannheim, Baden-Württemberg, Germany, 68167

Not yet recruiting

Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin
Mannheim

Sachsen-Anhalt Locations
Halle (Saale), Sachsen-Anhalt, Germany, 06120

Not yet recruiting

Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin
IV

Sachsen Locations
Dresden, Sachsen, Germany, 01307

Not yet recruiting

Gemeinschaftspraxis Hämatologie - Onkologie

Hungary
Fejer Locations
Székesfehérvár, Fejer, Hungary, 8000

Not yet recruiting

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Győr-Moson-Sopron Locations
Győr, Győr-Moson-Sopron, Hungary, 9024

Not yet recruiting

Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Szabolcs-Szatmár-Bereg Locations
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400

Recruiting

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház

Tolna Locations
Szekszárd, Tolna, Hungary, 7100

Recruiting

Tolna Vármegyei Megyei Balassa János Kórház

Ireland
Cork, Ireland

Recruiting

Cork University Hospital

Dublin, Ireland, 15

Not yet recruiting

Connolly Hospital Blanchardstown

Dublin, Ireland, 7

Not yet recruiting

Mater Misericordiae University Hospital

Israel
Haifa, Israel, 31048

Recruiting

Bnai Zion Medical Center

Haifa, Israel, 34362

Recruiting

Carmel Medical Center

Tel-Aviv Locations
Tel Aviv-Yafo, Tel-Aviv, Israel, 60000

Recruiting

Assuta Medical Center

Yerushalayim Locations
Jerusalem, Yerushalayim, Israel, 91120

Recruiting

Hadassah Medical Center - PPDS

Italy
Calabria Locations
Reggio Calabria, Calabria, Italy, 89133

Not yet recruiting

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Emilia-Romagna Locations
Bologna, Emilia-Romagna, Italy, 40138

Recruiting

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura
A Carattere Scientifico

Meldola, Emilia-Romagna, Italy, 47014

Recruiting

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l

Reggio Emilia, Emilia-Romagna, Italy, 42123

Recruiting

Azienda USL IRCCS di Reggio Emilia

Friuli-Venezia Giulia Locations
Udine, Friuli-Venezia Giulia, Italy, 33100

Recruiting

Azienda Sanitaria Universitaria Friuli Centrale

Lazio Locations
Roma, Lazio, Italy, 00128

Recruiting

Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Lombardia Locations
Bergamo, Lombardia, Italy, 24127

Not yet recruiting

Azienda Ospedaliera Papa Giovanni XXIII

Milano, Lombardia, Italy, 20122

Recruiting

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Marche Locations
Ancona, Marche, Italy, 60126

Recruiting

Azienda Ospedaliero Universitaria delle Marche

Piemonte Locations
Cuneo, Piemonte, Italy, 12100

Recruiting

Azienda Sanitaria Ospedaliera S. Croce e Carle

Novara, Piemonte, Italy, 28100

Recruiting

A.O.U. Maggiore della Carità

Torino, Piemonte, Italy, 10126

Not yet recruiting

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Puglia Locations
Bari, Puglia, Italy, 70124

Not yet recruiting

Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.

Sicilia Locations
Catania, Sicilia, Italy, 95123

Not yet recruiting

Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania

Palermo, Sicilia, Italy, 90127

Recruiting

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Toscana Locations
Firenze, Toscana, Italy, 50134

Recruiting

Azienda Ospedaliera Universitaria Careggi

Netherlands
Noord-Holland Locations
Hoofddorp, Noord-Holland, Netherlands, 2134 TM

Not yet recruiting

Spaarne Gasthuis

Overijssel Locations
Enschede, Overijssel, Netherlands, 7512 KZ

Not yet recruiting

Medisch Spectrum Twente

Zuid-Holland Locations
Dordrecht, Zuid-Holland, Netherlands, 3318 AT

Not yet recruiting

Albert Schweitzer Ziekenhuis

Poland
Poznań, Poland, 60-549

Not yet recruiting

Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny

Wałbrzych, Poland, 58-309

Not yet recruiting

Specjalistyczny Szpital im. dra Alfreda Sokołowskiego

Wrocław, Poland, 50-367

Not yet recruiting

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu

Serbia
Belgrade, Serbia, 11000

Recruiting

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia, 11000

Recruiting

Clinical Hospital Center Zemun

Belgrade, Serbia, 11000

Recruiting

University Clinical Center of Serbia

Nis, Serbia, 18000

Recruiting

University Clinical Center Nis

Novi Sad, Serbia, 21000

Recruiting

Clinical Center of Vojvodina

Spain
Alicante, Spain, 3010

Recruiting

Hospital General Universitario Dr. Balmis

Madrid, Spain, 28034

Recruiting

Hospital Universitario Ramon y Cajal

Málaga, Spain, 29010

Recruiting

Hospital Universitario Virgen de la Victoria

Valencia, Spain, 46026

Recruiting

Hospital Universitari i Politecnic La Fe de Valencia

Barcelona Locations
Badalona, Barcelona, Spain, 8916

Not yet recruiting

ICO Badalona-H.U. Germans Trias i Pujol

United Kingdom
Belfast, United Kingdom, BT9 7AB

Not yet recruiting

Belfast City Hospital

London, United Kingdom, W12 0HS

Recruiting

Imperial College Healthcare NHS Trust

Click to view interactive map


PARTICIPATION CRITERIA

Researchers look for people who fit a certain description, called eligibility
criteria. Some examples of these criteria are a person's general health
condition or prior treatments.

For general information about clinical research, read Learn About
Studies(https://www.clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

 * Patients must have been diagnosed with PV according to the 2016 WHO criteria
   within 3 years before randomization
 * Patients must have JAK2V617F-positive disease

 * Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at
   screening as follows:
   
   * Age ≥ 60 years, and/or
   * Prior thrombosis.

 * Patients must be in need of treatment at screening, defined by the presence
   of at least one of the following:
   
   * HCT ≥ 45% or HCT < 45% with at least 1 phlebotomy performed in the 3 months
     before screening, or
   * WBC count > 10 × 109/L, or
   * PLT count > 400 × 109/L.
 * Patients must have normalized HCT (i.e., HCT < 45%) at randomization

Exclusion Criteria:

 * Patients pre-treated with HU with a documented history of resistance or
   intolerance to HU defined by the original ELN criteria
 * Patients with a QTcF value of > 450 msec for males and > 460 msec for females
   at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart
   in the event a first ECG demonstrates a prolonged QTcF interval); congenital
   or acquired history of QTc prolongation or ventricular arrhythmias, at the
   Screening visit
 * Splanchnic thrombosis and/or thrombosis of the cerebral venous sinuses and/or
   splenectomy in the medical history
 * Patients with clinically significant cardiovascular disease
 * Patients with myocardial infarction, stroke or unstable angina within the 6
   months prior to screening.
 * Patients with inadequate liver or renal function at screening
 * Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 ×
   ULN
 * Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus
   (radioactive isotope) therapy.
 * Patients being treated concurrently with any investigational agent or prior
   participation in an interventional clinical study within the 30 days prior to
   screening or within 5 half-lives of the investigational product, whichever is
   longer.
 * Pregnant or nursing women

Show less
Ages Eligible for Study
18 Years and older (Adult,  Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No


STUDY PLAN

This section provides details of the study plan, including how the study is
designed and what the study is measuring.

Expand all / Collapse all
How is the study designed?
Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Single (Outcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment Participant Group/Arm Experimental:
Givinostat Intervention/Treatment Drug: Givinostat

 * Oral.

   
   

Participant Group/Arm Active Comparator: Hydroxyurea Intervention/Treatment
Drug: Hydroxyurea

 * Oral.

   
   

What is the study measuring?
Primary Outcome Measures

Outcome Measure Measure Description Time Frame Proportion of patients achieving
a response at Week 48.

Response assessment based on:

 * Hematocrit < 45% without phlebotomy in the prior 3 months, and
 * White blood cell (WBC) count ≤ 10 × 109/L, and
 * Platelet count ≤ 400 × 109/L, and
 * Normal spleen size as measured by imaging (normal spleen size is defined as:
   a longitudinal diameter ≤ 12 cm for female and ≤ 13 cm for male) and
 * During Part 2 (Week 25 to 48), absence of progressive disease, major
   hemorrhagic events and major thrombotic events.

week 25 - week 48

Secondary Outcome Measures

Outcome Measure Measure Description Time Frame Proportion of patients achieving
a complete hematological response (CHR) at Week 48.

CHR based on:

 * Hematocrit < 45% without phlebotomy in the prior 3 months, and
 * White blood cell (WBC) count ≤ 10 × 109/L, and
 * Platelet count ≤ 400 × 109/L

week 48Time from randomization to the first observed CHR Randomization - week
48Proportion of patients with a normal spleen size at Week 48. week 48Safety and
tolerability up to Week 48. Randomization - week 48


COLLABORATORS AND INVESTIGATORS

This is where you will find people and organizations involved with this study.
Sponsor
Italfarmaco


STUDY RECORD DATES

These dates track the progress of study record and summary results submissions
to ClinicalTrials.gov. Study records and reported results are reviewed by the
National Library of Medicine (NLM) to make sure they meet specific quality
control standards before being posted on the public website.
Study Registration Dates
First Submitted
2023-10-10
First Submitted that Met QC Criteria
2023-10-19
First Posted
2023-10-23
Study Record Updates
Last Update Submitted that met QC Criteria
2024-12-05
Last Update Posted
2024-12-06
Last Verified
2024-07


MORE INFORMATION

Record History
Expand all / Collapse all


TERMS RELATED TO THIS STUDY

Additional Relevant MeSH Terms
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders
Polycythemia Vera
Polycythemia
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Hydroxyurea


PLAN FOR INDIVIDUAL PARTICIPANT DATA (IPD)

Plan to Share Individual Participant Data (IPD)?
No


DRUG AND DEVICE INFORMATION, STUDY DOCUMENTS, AND HELPFUL LINKS

Studies a U.S. FDA-Regulated Drug Product
Yes
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