Hypertrophic Cardiomyopathy Clinical Trial
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
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.
Eligibility 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.
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There are 67 Locations for this study
Scottsdale Arizona, 85259, United States
Los Angeles California, 90027, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
New Haven Connecticut, 06520, United States
Jacksonville Florida, 32224, United States
Chicago Illinois, 60611, United States
Indianapolis Indiana, 46260, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
Grand Rapids Michigan, 49503, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
New York New York, 10032, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45267, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18015, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Memphis Tennessee, 38104, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Murray Utah, 84107, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22903, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
Aalst , 9300, Belgium
Brussels , 1070, Belgium
Edegem , 2650, Belgium
Prague , 140 2, Czechia
Praha 2 , 128 0, Czechia
Aarhus , 8000, Denmark
Frederiksberg , 2000, Denmark
Odense , 5000, Denmark
Nantes , 44093, France
Paris , 75013, France
Paris , 75015, France
Toulouse , 31059, France
Bad Nauheim , 61231, Germany
Dresden , 01277, Germany
Goettingen , 37075, Germany
Heidelberg , 69120, Germany
Jerusalem , 91120, Israel
Petah Tikva , 49414, Israel
Ramat-gan , 52621, Israel
Rehovot , 76100, Israel
Safed , 13100, Israel
Tel Aviv , 64239, Israel
Firenze , 50139, Italy
Maastricht , 6229 , Netherlands
Rotterdam , 3015 , Netherlands
Katowice , 40-55, Poland
Krakow , 31-50, Poland
Poznan , 61-84, Poland
Warsaw , 04-62, Poland
Almada , 2805-, Portugal
Lisboa , 1500-, Portugal
A Coruña , 15006, Spain
El Palmar , 30120, Spain
Madrid , 28034, Spain
Majadahonda , 28222, Spain
Sevilla , 41009, Spain
London , W1G 8, United Kingdom
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