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

March 5, 2024 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

282

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

  • Belgium
      • Aalst, Belgium, 9300
        • Local Institution - 0002
      • Brussels, Belgium, 1070
        • Local Institution - 0001
      • Edegem, Belgium, 2650
        • Local Institution - 0003
  • Czechia
      • Prague, Czechia, 140 21
        • Local Institution - 0009
      • Praha 2, Czechia, 128 08
        • Local Institution - 0010
  • Denmark
      • Aarhus, Denmark, 8000
        • Local Institution - 0011
      • Frederiksberg, Denmark, 2000
        • Local Institution - 0012
      • Odense, Denmark, 5000
        • Local Institution - 0013
  • France
      • Nantes, France, 44093
        • Local Institution - 0014
      • Paris, France, 75013
        • Local Institution - 0017
      • Paris, France, 75015
        • Local Institution - 0016
      • Toulouse, France, 31059
        • Local Institution - 0015
  • Germany
      • Bad Nauheim, Germany, 61231
        • Local Institution - 0020
      • Dresden, Germany, 01277
        • Local Institution - 0018
      • Goettingen, Germany, 37075
        • Local Institution - 0019
      • Heidelberg, Germany, 69120
        • Local Institution - 0021
  • Israel
      • Jerusalem, Israel, 9112001
        • Local Institution - 0027
      • Petah Tikva, Israel, 4941492
        • Local Institution - 0024
      • Ramat-gan, Israel, 52621
        • Local Institution - 0022
      • Rehovot, Israel, 76100
        • Local Institution - 0025
      • Safed, Israel, 13100
        • Local Institution - 0023
      • Tel Aviv, Israel, 6423906
        • Local Institution - 0026
  • Italy
      • Firenze, Italy, 50139
        • Local Institution - 0028
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Local Institution - 0029
      • Rotterdam, Netherlands, 3015 CE
        • Local Institution - 0030
  • Poland
      • Katowice, Poland, 40-555
        • Local Institution - 0033
      • Krakow, Poland, 31-501
        • Local Institution - 0034
      • Poznan, Poland, 61-848
        • Local Institution - 0031
      • Warsaw, Poland, 04-628
        • Local Institution - 0032
  • Portugal
      • Almada, Portugal, 2805-267
        • Local Institution - 0036
      • Lisboa, Portugal, 1500-650
        • Local Institution - 0035
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0038
      • El Palmar, Spain, 30120
        • Local Institution - 0037
      • Madrid, Spain, 28034
        • Local Institution - 0040
      • Majadahonda, Spain, 28222
        • Local Institution - 0039
      • Sevilla, Spain, 41009
        • Local Institution - 0041
  • United Kingdom
      • London, United Kingdom, W1G 8PH
        • Local Institution - 0042
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Local Institution - 0045
    • California
      • Los Angeles, California, United States, 90027
        • Local Institution - 0058
      • San Francisco, California, United States, 94143
        • Local Institution - 0066
      • Stanford, California, United States, 94305
        • Local Institution - 0063
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8017
        • Local Institution - 0043
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0067
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0050
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Local Institution - 0070
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Local Institution - 0049
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Local Institution - 0054
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0051
      • Grand Rapids, Michigan, United States, 49503
        • Local Institution - 0074
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0048
    • New York
      • New York, New York, United States, 10016
        • Local Institution - 0060
      • New York, New York, United States, 10032
        • Local Institution - 0056
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0071
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0047
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Local Institution - 0052
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 0044
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Local Institution - 0068
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0046
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0064
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Local Institution - 0073
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution - 0061
      • Houston, Texas, United States, 77030
        • Local Institution - 0057
      • Houston, Texas, United States, 77030
        • Local Institution - 0055
    • Utah
      • Murray, Utah, United States, 84107-5701
        • Local Institution - 0072
      • Salt Lake City, Utah, United States, 84112
        • Local Institution - 0062
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Local Institution - 0053
      • Richmond, Virginia, United States, 23298
        • Local Institution - 0059
    • Washington
      • Seattle, Washington, United States, 98195
        • Local Institution - 0065

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Active Treatment for participants with base target trough concentration
Drug: mavacamten
mavacamten capsules
Other Names:
  • MYK-461
Experimental: Group 2
Active Treatment for participants with higher target trough concentration
Drug: mavacamten
mavacamten capsules
Other Names:
  • MYK-461
Experimental: Group 3
Active Treatment for participants dose titrated to clinical response
Drug: mavacamten
mavacamten capsules
Other Names:
  • MYK-461

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of treatment-emergent adverse events and serious adverse events
Time Frame: 252 weeks
252 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

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.

Helpful Links

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)

October 5, 2018

Primary Completion (Estimated)

March 15, 2030

Study Completion (Estimated)

March 15, 2030

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-003

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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