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A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723655
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.

Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.

Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.


Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Obstructive Hypertrophic Cardiomyopathy Non-obstructive Hypertrophic Cardiomyopathy Drug: mavacamten Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Site, Care Provider and Patients are blinded to study dose. Sponsor is now unblinded to study dose.
Primary Purpose: Treatment
Official Title: A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : April 16, 2026
Estimated Study Completion Date : April 16, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Active Treatment for participants with base target trough concentration
 Drug: mavacamten
mavacamten capsules
Other Name: MYK-461
Experimental: Group 2
Active Treatment for participants with higher target trough concentration
 Drug: mavacamten
mavacamten capsules
Other Name: MYK-461
Experimental: Group 3
Active Treatment for participants dose titrated to clinical response
 Drug: mavacamten
mavacamten capsules
Other Name: MYK-461


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and severity of treatment-emergent adverse events and serious adverse events [ Time Frame: 252 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included in this study pending MyoKardia Medical Monitoring approval) Participants who prematurely discontinued from the Parent Study or the MAVA-LTE study may be considered for inclusion.
  • Has a body weight greater than 45 kg at the Screening Visit
  • Has adequate acoustic windows to enable accurate TTEs.
  • Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTE at rest.
  • Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range).
  • Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP).

In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).

Key Exclusion Criteria:

  • Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II).
  • Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit.
  • Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the study.
  • Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.
  • History of clinically significant malignant disease that developed since enrollment in the Parent Study.
  • Is unable to comply with the study requirements, including the number of required visits to the clinical site.
  • Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.
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): NCT03723655


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03723655    
Other Study ID Numbers: CV027-003
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023

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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 Bristol-Myers Squibb:
Symptomatic, left ventricular outflow tract gradient
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
Aortic Valve Disease
Heart Valve Diseases