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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: Eleclazine Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : February 17, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: GS-6615

Drug: Placebo
Placebo to match eleclazine administered orally once daily


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

Secondary Outcome Measures :
  1. Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291237


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

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] April 1, 2014
Study Protocol: Amendment 1  [PDF] October 10, 2014
Study Protocol: Amendment 2  [PDF] February 10, 2015
Study Protocol: Amendment 3  [PDF] August 12, 2016
Statistical Analysis Plan  [PDF] May 10, 2017

More Information
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Publications:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02291237     History of Changes
Other Study ID Numbers: GS-US-361-1157
2013-004429-97 ( EudraCT Number )
First Posted: November 14, 2014    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: September 24, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
hypertrophic cardiomyopathy
hocm
hypertrophic myocardiopathy
hypertrophic obstructive cardiomyopathies
cardiomyopathy
hypertrophic
familial hypertrophic cardiomyopathy
GS-6615
hcm
genetic heart disease
 echocardiography
cardiopulmonary exercise testing
exercise Capacity
heart failure
angina
dyspnea
diastolic dysfunction
microvascular ischemia
late sodium current inhibitor
late INA
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases