Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM)

August 24, 2018 updated by: Gilead Sciences

Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

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.

Intervention / Treatment

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

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 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
  • France
      • Paris, France
        • Hopital Europeen Georges Pompidou
  • Germany
      • Hamburg, Germany
        • Universitatsklinikum Hamburg Eppendorf
  • Israel
      • Jerusalem, Israel
        • Ein Kerem-Hadassah Medical Organization
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Ramat-Gan, Israel
        • Sheba Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bergamo, Italy
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bologna, Italy
        • Azienda Ospedaliero Universitaria di Bologna
      • Florence, Italy
        • Azienda Ospedaliera Universitaria Careggi
      • Milan, Italy
        • Ospedale San Raffaele S.r.l.
      • Naples, Italy
        • Azienda Ospedaliera Monaldi
      • Parma, Italy
        • Azienda Ospedaliero Universitaria di Parma
      • Rome, Italy
        • Azienda Ospedaliera San Camillo Forlanini
    • Ascoli Piceno
      • San Benedetto del Tronto, Ascoli Piceno, Italy
        • Madonna del Soccorso Hospital
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus MC
      • Utrecht, Netherlands
        • University Medical Center Utrecht
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Academisch Medisch Centrum Amsterdam
  • United Kingdom
    • South Glamergon
      • Cardiff, South Glamergon, United Kingdom
        • University Hospital of Wales
    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom
        • Northern General Hospital
  • United States
    • California
      • Los Angeles, California, United States
        • University of California Los Angeles
      • Los Angeles, California, United States
        • Cedars-Sinai Heart Institute
      • Stanford, California, United States
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale New Haven Hospital
    • Georgia
      • Athens, Georgia, United States
        • Athens Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa Hospitals and Clinics
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States
        • Tufts Medical Center
      • Boston, Massachusetts, United States
        • Brigham & Women's Hospital and Harvard Medical School
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
    • New Jersey
      • Morristown, New Jersey, United States
        • Morristown Medical Center
    • New York
      • New York, New York, United States
        • Columbia University Medical Center/ New York Presbyterian
      • New York, New York, United States
        • NYU School of Medicine Pediatrics
    • North Carolina
      • Durham, North Carolina, United States
        • Duke Health Center at Southpoint
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health and Science University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
        • St. Luke's University Health Network
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States
        • St. Thomas Research Institute
    • Texas
      • Houston, Texas, United States
        • Houston Methodist Hospital
      • Houston, Texas, United States
        • Texas Heart Institute
      • Houston, Texas, United States
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States
        • University of Washington
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Marshfield Clinic Research Institute
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

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.

Eligibility Criteria

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.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis

  • Exertional symptoms including at least one of the following:

    • New York Heart Association (NYHA) Class ≥ II dyspnea
    • Canadian Cardiovascular Society (CCS) Class ≥ II angina
  • Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight
  • Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Key Exclusion Criteria:

  • Known aortic valve stenosis (moderate or severe)
  • Known coronary artery disease
  • Left ventricular systolic dysfunction (ejection fraction < 50%)
  • Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / 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.
Intervention / Treatment

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.
Experimental: Eleclazine
Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.
Drug: Eleclazine
Tablet (s) administered orally once daily
Other Names:
  • GS-6615
Experimental: Placebo
Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
Drug: Eleclazine
Tablet (s) administered orally once daily
Other Names:
  • GS-6615
Drug: Placebo
Placebo to match eleclazine administered orally once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

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.
Outcome Measure
Time Frame
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24
Time Frame: Baseline to Week 24
The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Baseline to Week 24
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12
Time Frame: Baseline to Week 12
The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Baseline to Week 12
Change in Treadmill Exercise Time From Baseline to Week 24
Time Frame: Baseline to Week 24
Treadmill exercise time is the time to peak exercise.
Baseline to Week 24
Change in Treadmill Exercise Time From Baseline to Week 12
Time Frame: Baseline to Week 12
Treadmill exercise time is the time to peak exercise.
Baseline to Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2015

Primary Completion (Actual)

Primary Completion

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 "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2017

Study Registration Dates

First Submitted

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).
November 11, 2014

First Submitted That Met QC Criteria

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.
November 11, 2014

First Posted (Estimate)

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.
November 14, 2014

Study Record Updates

Last Update Posted (Actual)

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.
September 24, 2018

Last Update Submitted That Met QC Criteria

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.
August 24, 2018

Last Verified

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.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

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.
  • GS-US-361-1157
  • 2013-004429-97 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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