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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 : Enrolling by invitation
First Posted : October 29, 2018
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
MyoKardia, Inc.

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE October 5, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Frequency and severity of treatment-emergent adverse events and serious adverse events [ Time Frame: 104 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
Official Title  ICMJE 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)
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.

Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

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: Triple (Participant, Care Provider, Investigator)
Masking Description:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertrophic Cardiomyopathy
  • Obstructive Hypertrophic Cardiomyopathy
  • Non-obstructive Hypertrophic Cardiomyopathy
Intervention  ICMJE Drug: mavacamten
mavacamten capsules
Other Name: MYK-461
Study Arms  ICMJE
  • Experimental: Group 1
    Active Treatment for participants with base target trough concentration
    Intervention: Drug: mavacamten
  • Experimental: Group 2
    Active Treatment for participants with higher target trough concentration
    Intervention: Drug: mavacamten
  • Experimental: Group 3
    Active Treatment for participants dose titrated to clinical response
    Intervention: Drug: mavacamten
Publications * Not Provided

*   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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 10, 2020)
310
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
60
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • 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 QTcF > 500 ms at Screening or any other 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Belgium,   Czechia,   Denmark,   France,   Germany,   Israel,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723655
Other Study ID Numbers  ICMJE MYK-461-007
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 MyoKardia, Inc.
Study Sponsor  ICMJE MyoKardia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Information Team MyoKardia, Inc.
PRS Account MyoKardia, Inc.
Verification Date February 2019

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