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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • 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
        • Universitätsklinikum 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

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
Intervention / Treatment
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

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

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

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)

February 5, 2015

Primary Completion (Actual)

January 20, 2017

Study Completion (Actual)

February 17, 2017

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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