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

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ClinicalTrials.gov Identifier: NCT02291237
Recruitment Status : Terminated
First Posted : November 14, 2014
Results First Posted : March 22, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Results First Submitted Date  ICMJE January 19, 2018
Results First Posted Date  ICMJE March 22, 2018
Last Update Posted Date September 24, 2018
Actual Study Start Date  ICMJE February 5, 2015
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
Change in peak oxygen uptake (VO2) from baseline (screening) to Week 24 [ Time Frame: Up to 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12 [ Time Frame: 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24 [ Time Frame: Up to 24 weeks ]
  • Change in Treadmill Exercise Time From Baseline to Week 24 [ Time Frame: Up to 24 weeks ]
  • Change in Peak VO2 from baseline to Week 12 [ Time Frame: Up to 12 weeks ]
  • Change in the MLHFQ from baseline to Week 12 [ Time Frame: Up to 12 weeks ]
  • Change in Treadmill Exercise Time From Baseline to Week 12 [ Time Frame: Up to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertrophic Cardiomyopathy
Intervention  ICMJE
  • Drug: Eleclazine
    Tablet (s) administered orally once daily
    Other Name: GS-6615
  • Drug: Placebo
    Placebo to match eleclazine administered orally once daily
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Eleclazine
  • Experimental: Placebo
    Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
    Interventions:
    • Drug: Eleclazine
    • Drug: Placebo
Publications * Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 23, 2016)
172
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
180
Actual Study Completion Date  ICMJE February 17, 2017
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Germany,   Israel,   Italy,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291237
Other Study ID Numbers  ICMJE GS-US-361-1157
2013-004429-97 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP