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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03723655
Collaborator
(none)
282
Enrollment
69
Locations
3
Arms
90.3
Anticipated Duration (Months)
4.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 5, 2018
Anticipated Primary Completion Date :
Apr 16, 2026
Anticipated Study Completion Date :
Apr 16, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency and severity of treatment-emergent adverse events and serious adverse events [252 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona - Scottsdale Scottsdale Arizona United States 85259
    2 Cedars-Sinai Medical Center Los Angeles California United States 90027
    3 University Of California San Francisco San Francisco California United States 94143
    4 Stanford University Stanford California United States 94305
    5 Yale University School of Medicine New Haven Connecticut United States 06520-8017
    6 Mayo Clinic Jacksonville - PPDS Jacksonville Florida United States 32224
    7 Northwestern University Chicago Illinois United States 60611
    8 St. Vincent Indianapolis Hospital And Health Care Center Indianapolis Indiana United States 46260
    9 University Of Iowa Hospitals And Clinics Iowa City Iowa United States 52242
    10 Brigham And Women'S Hospital Boston Massachusetts United States 02115
    11 University Of Michigan Ann Arbor Michigan United States 48109
    12 Local Institution Detroit Michigan United States 48202
    13 Spectrum Health Hospitals Grand Rapids Michigan United States 49503
    14 Washington University School of Medicine Saint Louis Missouri United States 63110
    15 NYU Langone Medical Center New York New York United States 10016
    16 Columbia University Medical Center (Cumc) New York New York United States 10032
    17 Carolinas Healthcare System Charlotte North Carolina United States 28204
    18 Duke University Medical Center Durham North Carolina United States 27710
    19 University of Cincinnati Cincinnati Ohio United States 45267
    20 Oregon Health & Science University Portland Oregon United States 97239
    21 St. Lukes Health Network, Inc. d/b/a Bethlehem Pennsylvania United States 18015
    22 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    23 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    24 Methodist University Hospital Memphis Tennessee United States 38104
    25 University of Texas Southwestern Medical Center Dallas Texas United States 75390-88520
    26 Houston Methodist Hospital Houston Texas United States 77030
    27 University Of Texas Medical School - Houston Houston Texas United States 77030
    28 Intermountain Medical Center Murray Utah United States 84107
    29 University of Utah Salt Lake City Utah United States 84112
    30 University of Virginia Health System Charlottesville Virginia United States 22903
    31 Virginia Commonwealth University Richmond Virginia United States 23298
    32 University of Washington Medical Center Seattle Washington United States 98195
    33 Onze-Lieve-Vrouwziekenhuis Aalst Belgium 9300
    34 Hôpital Erasme Brussels Belgium 1070
    35 UZ Antwerpen Edegem Belgium 2650
    36 Institut klinicke a experimentalni mediciny Prague Czechia 140 21
    37 Vseobecna Fakultni Nemocnice V Praze Praha 2 Czechia 128 08
    38 Aarhus Universitetshospital Aarhus Denmark 8000
    39 Frederiksberg Hospital Frederiksberg Denmark 2000
    40 Odense Universitetshospital Odense Denmark 5000
    41 CHRU Nantes Nantes France 44093
    42 Groupe Hospitalier Pitié Salpétrière Paris France 75013
    43 Hôpital Européen Georges Pompidou Paris France 75015
    44 Hôpital de Rangueil Toulouse France 31059
    45 Kerckhoff-Klinik-Forschungs-GmbH Bad Nauheim Germany 61231
    46 Cardiologicum Dresden und Pirna Dresden Germany 01277
    47 University Medicine Göttingen Germany Göttingen Germany 37075
    48 University Clinic Heidelberg - PPDS Heidelberg Germany 69120
    49 Hadassah Medical Center PPDS Jerusalem Israel 9112001
    50 Rabin Medical Center - PPDS Petah Tikva Israel 4941492
    51 Sheba Medical Center - PPDS Ramat-gan Israel 52621
    52 Kaplan Medical Center Rehovot Israel 76100
    53 ZIV Medical Center Safed Israel 13100
    54 Tel Aviv Sourasky Medical Center PPDS Tel Aviv Israel 6423906
    55 Azienda Ospedaliera Universitaria Careggi Firenze Italy 50139
    56 Maastricht University Medical Center Maastricht Netherlands 6229 HX
    57 Erasmus MC Rotterdam Netherlands 3015 CE
    58 Kardio Klinika Brynów Katowice Poland 40-555
    59 Collegium Medicum Uniwersytetu Jagiellonskiego Krakow Poland 31-501
    60 Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego Poznan Poland 61-848
    61 Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego Warsaw Poland 04-628
    62 Hospital Garcia de Orta Almada Portugal 2805-267
    63 Hospital da Luz Lisboa Portugal 1500-650
    64 Hospital Universitario A Coruña A Coruña Spain 15006
    65 Hospital Universitario Virgen de La Arrixaca El Palmar Spain 30120
    66 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    67 Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Spain 28222
    68 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    69 St Bartholomew's Hospital London United Kingdom W1G 8PH

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03723655
    Other Study ID Numbers:
    • CV027-003
    First Posted:
    Oct 29, 2018
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    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:
    Cardiomyopathies
    Cardiomyopathy, Hypertrophic
    Hypertrophy

    Study Results

    No Results Posted as of Jun 14, 2022