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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
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Recruiting


AFFINITY DUCHENNE: RGX-202 GENE THERAPY IN PARTICIPANTS WITH DUCHENNE MUSCULAR
DYSTROPHY (DMD)

ClinicalTrials.gov ID NCT05693142
Sponsor REGENXBIO Inc.
Information provided by REGENXBIO Inc. (Responsible Party)
Last Update Posted 2024-07-23
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

RGX-202 is a gene therapy designed to deliver a transgene for a novel
microdystrophin that includes functional elements of naturally-occurring
dystrophin including the C-Terminal (CT) domain.

This is a multicenter, open-label dose evaluation clinical study to assess the
safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose
of RGX-202 in participants with Duchenne.

Detailed Description

Duchenne muscular dystrophy (Duchenne) is a rare genetic disorder, caused by
mutations in the gene responsible for making dystrophin, a protein of central
importance for muscle cell structure and function. The absence of functional
dystrophin protein in individuals with Duchenne results in cell damage during
muscle contraction leading to cell death, inflammation, and fibrosis in muscle
tissues, and ultimately progressive muscle weakness. RGX-202 is designed to use
the AAV8 vector to deliver a transgene to muscle cells that encodes a novel
microdystrophin that includes the functional elements of naturally occurring
dystrophin including the C-Terminal (CT) domain. This is a Phase 1/2,
multicenter, open-label, dose evaluation clinical study to assess the safety,
tolerability, pharmacodynamics (microdystrophin protein levels),
pharmacokinetics, and preliminary clinical efficacy of RGX-202 in 2 dose groups
over 52 weeks when administered by one-time intravenous infusion (IV) in
ambulatory male pediatric participants with Duchenne.

The first 2 participants (ages 4-11 years old) in the first dose group (Cohort
1) will be dosed with 1x10^14 genome copies (GC)/kg body weight in a staggered
fashion, at least 4 weeks apart, following increasing body weight: ≤25kg and
≤35kg. After an independent safety data review, 2 participants (ages 4-11 years
old) in the second dose group (Cohort 2) will be dosed with 2x10^14 GC/kg body
weight in a staggered fashion, at least 4 weeks apart, following increasing body
weight: ≤25kg and ≤35kg. After an independent safety data review, an expansion
phase of Cohort 2 may allow for up to five additional participants (ages 4-11
years old) to be enrolled. A separate group (Cohort 1b) was added and expected
to enroll in the first dose group, a single patient, 4-11 years old, with
at-risk mutations (premature stop codon mutation in exons 12-17). An additional
group was added for the second dose group (Cohort 2c) and expected to enroll up
to five, 1-3-years-old participants, must be ≥ 10 kg at the time of screening. A
total of up to 15 participants may be enrolled in the study with 3 participants
receiving dose level 1 and up to 12 participants receiving dose level 2.

A comprehensive, short-term, prophylactic immunosuppression regimen will be
administered during treatment to mitigate a potential immune response.

Show less
Official Title
A Phase 1/2 Open-label, Dose Escalation and Dose Expansion Study to Evaluate the
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Intravenous
RGX-202 Gene Therapy in Males With Duchenne Muscular Dystrophy (DMD)
Conditions
Duchenne Muscular Dystrophy
Intervention / Treatment
 * Genetic: RGX-202
   

 * Genetic: RGX-202

Other Study ID Numbers
 * RGX-202-1101
   
   

Study Start (Actual)
2023-01-04
Primary Completion (Estimated)
2025-12
Study Completion (Estimated)
2025-12
Enrollment (Estimated)
15
Study Type
Interventional
Phase
Phase 1Phase 2

RESOURCE LINKS PROVIDED BY THE NATIONAL LIBRARY OF MEDICINE

MedlinePlus(https://medlineplus.gov/) related topics:  Genes and Gene
Therapy(https://medlineplus.gov/genesandgenetherapy.html)  Muscular
Dystrophy(https://medlineplus.gov/musculardystrophy.html) 
Genetic and Rare Diseases Information
Center(https://rarediseases.info.nih.gov/gard) resources:  Muscular
Dystrophy(https://rarediseases.info.nih.gov/diseases/7922/muscular-dystrophy) 
Becker Muscular
Dystrophy(https://rarediseases.info.nih.gov/diseases/5900/becker-muscular-dystrophy) 
Duchenne Muscular
Dystrophy(https://rarediseases.info.nih.gov/diseases/6291/duchenne-muscular-dystrophy) 
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: Patient Advocacy

Phone Number: (833) 711-0349

Email: Duchenne@regenxbio.com

This study has 5 locations
United States
Arkansas Locations
Little Rock, Arkansas, United States, 72202

Recruiting

Arkansas Children's Hospital

Contact:
Amber Evans
501-364-2259 evansa17@archildrens.org
Principal Investigator:
Aravindhan Veerapandiyan, MD
California Locations
Palo Alto, California, United States, 94304

Recruiting

Stanford School of Medicine /Division of Neuromuscular Medicine

Contact:
Yan Yang
650-206-3180 yyang4@stanford.edu
Principal Investigator:
Carolina Tesi-Rocha, MD
Illinois Locations
Chicago, Illinois, United States, 60611

Recruiting

Ann & Robert H. Lurie Children's Hospital of Chicago

Contact:
Molly Gallivan
312-227-3813 megallivan@luriechildrens.org
Principal Investigator:
Vamshi Rao, MD
Texas Locations
Dallas, Texas, United States, 75390

Recruiting

The University of Texas Southwestern Medical Center

Contact:
Elaine Most
214-456-2463 elaine.most@utsouthwestern.edu
Principal Investigator:
Susan Iannaccone, MD
Virginia Locations
Richmond, Virginia, United States, 23298-0211

Recruiting

Children's Hospital of Richmond at Virginia Commonwealth University

Contact:
Mehreen Qureshi
804-628-7917 mehreen.qureshi@vcuhealth.org
Principal Investigator:
Amy Harper, MD
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:

 * DMD gene mutation in exons 18 and above, and a clinical picture consistent
   with typical DMD with the exception of a participant (Cohort 1b) with DMD
   gene mutation in exons 12-17.
 * Participant is able to walk 100 meters independently without assistive
   devices. Cohort 2c participant must be able to walk 10 meters independently
   without assistive devices. Cohort 1b participant must be able to walk with or
   without assistive devices.
 * Participant is able to complete the TTSTAND per protocol-specific criteria.
 * Participant has been on a stable dose of systemic glucocorticoids according
   to the standard of care for at least 12 weeks prior to obtaining the
   pharmacodynamic assessments, imaging assessments, patient-reported outcomes,
   and functional clinical outcome assessments within the Day -60 to Day -3
   screening period. Cohort 2c participants must be consistently on or off a
   stable dose of systemic glucocorticoids according to the standard of care for
   at least 12 weeks prior to obtaining the pharmacodynamic assessments, imaging
   assessments, patient-reported outcomes, and functional clinical outcomes
   assessments within the Day -60 to Day -3 screening period and the 12 month
   duration of the study.
 * Clinical laboratory test results, including hepatic and renal function, are
   within the normal range during screening, or if abnormal, are not clinically
   significant, in the opinion of the investigator.
 * Documentation is provided at screening visit for participant's adherence to
   the local country's vaccination schedule. The parent(s) or legal guardian(s)
   must be willing to have their child receive a meningococcal vaccine, if not
   already vaccinated.
 * Participant and parent(s)/legal guardian(s) are willing and able to comply
   with scheduled visits, study intervention administration plan, and study
   procedures.

Exclusion Criteria:

 * Participant has any condition that would contraindicate treatment with
   immunosuppression.
 * Participant has received ataluren (a protein restoration therapy) or an
   exon-skipping therapy for the treatment of DMD within 6 months of study entry
   or is unable to refrain from taking ataluren or exon-skipping therapy for a
   duration of 5 years from the time of RGX-202 administration.
 * Participant has received any investigational or commercial gene therapy
   product over his lifetime.
 * Participant is currently taking any other investigational intervention (other
   than corticosteroids) or has taken any other investigational intervention
   (other than corticosteroids) within 3 months prior to the scheduled Day 1
   intervention. If the corticosteroid is 6 mg/kg/day vamorolone, the
   participant must be converted to daily prednisolone or prednisone for a
   period of 12 weeks starting the day before the scheduled Day 1 intervention
   before being allowed to resume vamorolone at the original dose, unless the
   investigator determines that this is not clinically indicated or possible.
 * Participant has detectable AAV8 total binding antibodies in serum.
 * Participant has impaired cardiac function defined as a left ventricular
   ejection fraction of < 55% on screening cardiac assessments (echocardiogram
   or MRI).
 * Participant is not a good candidate for the study, in the opinion of the
   investigator.

Show less
Gender-based Eligibility
Yes
Ages Eligible for Study
1 Year to 11 Years (Child )
Sexes Eligible for Study
Male
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 : Non-Randomized
Interventional Model : Sequential Assignment
Interventional Model Description: Dose Evaluation
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment Participant Group/Arm Experimental:
RGX-202 Dose 1
A single IV infusion of RGX-202 at a dose of 1×10^14 GC/kg body weight
Intervention/Treatment Genetic: RGX-202

 * RGX-202 is a recombinant AAV8 containing a transgene encoding a novel
   microdystrophin

   
   

Participant Group/Arm Experimental: RGX-202 Dose 2
A single IV infusion of RGX-202 at a dose of 2x10^14 GC/kg body weight
Intervention/Treatment Genetic: RGX-202

 * RGX-202 is a recombinant AAV8 containing a transgene encoding a novel
   microdystrophin

   
   

What is the study measuring?
Primary Outcome Measures

Outcome Measure Measure Description Time Frame Safety measured by incidence of
Adverse Events and Serious Adverse EventsEvaluate incidences of AEs and SAEs52
weeks

Secondary Outcome Measures

Outcome Measure Measure Description Time Frame Efficacy measured by change in
Functional AssessmentChange from baseline in motor skills as measured by North
Star Ambulatory Assessment (NSAA).Multiple timepoints through 52 weeksEfficacy
measured by change in Functional AssessmentChange from baseline in motor skill
acquisition as measured by the Peabody Developmental Motor Scale-Third Edition
(PDMS-3).Multiple timepoints through 52 weeksMicrodystrophin protein
expressionRGX-202 microdystrophin protein levels determined in muscle biopsy and
the vector genome concentrations in muscle at assessed time points.12
weeksPharmacokinetics (PK)Vector genome concentrations as measured by polymerase
chain reaction [PCR] to RGX-202 deoxyribonucleic acid [DNA] in serum.Multiple
timepoints through 52 weeksVector SheddingVector genome concentrations as
measured by polymerase chain reaction [PCR] to RGX-202 deoxyribonucleic acid
[DNA] in urine.Multiple timepoints through 52 weeks


COLLABORATORS AND INVESTIGATORS

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


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
2023-01-04
First Submitted that Met QC Criteria
2023-01-12
First Posted
2023-01-20
Study Record Updates
Last Update Submitted that met QC Criteria
2024-07-19
Last Update Posted
2024-07-23
Last Verified
2024-07


MORE INFORMATION

Record History
Expand all / Collapse all


TERMS RELATED TO THIS STUDY

Keywords Provided by REGENXBIO Inc.
Gene therapy
DMD
Duchenne Muscular Dystrophy
Duchenne
Additional Relevant MeSH Terms
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Muscular Dystrophies
Muscular Dystrophy, Duchenne


DRUG AND DEVICE INFORMATION, STUDY DOCUMENTS, AND HELPFUL LINKS

Studies a U.S. FDA-Regulated Drug Product
Yes
Studies a U.S. FDA-Regulated Device Product
No
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