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

Hypertrophic Cardiomyopathy Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03723655
• Other study ID #: CV027-003
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 5, 2018
• Est. completion date: March 15, 2030

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 282
• Est. completion date: March 15, 2030
• Est. primary completion date: March 15, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Non-obstructive Hypertrophic Cardiomyopathy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Drug:
• mavacamten
mavacamten capsules

Locations

Country	Name	City	State
Belgium	Local Institution - 0002	Aalst
Belgium	Local Institution - 0001	Brussels
Belgium	Local Institution - 0003	Edegem
Czechia	Local Institution - 0009	Prague
Czechia	Local Institution - 0010	Praha 2
Denmark	Local Institution - 0011	Aarhus
Denmark	Local Institution - 0012	Frederiksberg
Denmark	Local Institution - 0013	Odense
France	Local Institution - 0014	Nantes
France	Local Institution - 0016	Paris
France	Local Institution - 0017	Paris
France	Local Institution - 0015	Toulouse
Germany	Local Institution - 0020	Bad Nauheim
Germany	Local Institution - 0018	Dresden
Germany	Local Institution - 0019	Goettingen
Germany	Local Institution - 0021	Heidelberg
Israel	Local Institution - 0027	Jerusalem
Israel	Local Institution - 0024	Petah Tikva
Israel	Local Institution - 0022	Ramat-gan
Israel	Local Institution - 0025	Rehovot
Israel	Local Institution - 0023	Safed
Israel	Local Institution - 0026	Tel Aviv
Italy	Local Institution - 0028	Firenze
Netherlands	Local Institution - 0029	Maastricht
Netherlands	Local Institution - 0030	Rotterdam
Poland	Local Institution - 0033	Katowice
Poland	Local Institution - 0034	Krakow
Poland	Local Institution - 0031	Poznan
Poland	Local Institution - 0032	Warsaw
Portugal	Local Institution - 0036	Almada
Portugal	Local Institution - 0035	Lisboa
Spain	Local Institution - 0038	A Coruña
Spain	Local Institution - 0037	El Palmar
Spain	Local Institution - 0040	Madrid
Spain	Local Institution - 0039	Majadahonda
Spain	Local Institution - 0041	Sevilla
United Kingdom	Local Institution - 0042	London
United States	Local Institution - 0051	Ann Arbor	Michigan
United States	Local Institution - 0068	Bethlehem	Pennsylvania
United States	Local Institution - 0054	Boston	Massachusetts
United States	Local Institution - 0071	Charlotte	North Carolina
United States	Local Institution - 0053	Charlottesville	Virginia
United States	Local Institution - 0050	Chicago	Illinois
United States	Local Institution - 0052	Cincinnati	Ohio
United States	Local Institution - 0061	Dallas	Texas
United States	Local Institution - 0047	Durham	North Carolina
United States	Local Institution - 0074	Grand Rapids	Michigan
United States	Local Institution - 0055	Houston	Texas
United States	Local Institution - 0057	Houston	Texas
United States	Local Institution - 0070	Indianapolis	Indiana
United States	Local Institution - 0049	Iowa City	Iowa
United States	Local Institution - 0067	Jacksonville	Florida
United States	Local Institution - 0058	Los Angeles	California
United States	Local Institution - 0073	Memphis	Tennessee
United States	Local Institution - 0072	Murray	Utah
United States	Local Institution - 0043	New Haven	Connecticut
United States	Local Institution - 0056	New York	New York
United States	Local Institution - 0060	New York	New York
United States	Local Institution - 0046	Philadelphia	Pennsylvania
United States	Local Institution - 0064	Pittsburgh	Pennsylvania
United States	Local Institution - 0044	Portland	Oregon
United States	Local Institution - 0059	Richmond	Virginia
United States	Local Institution - 0048	Saint Louis	Missouri
United States	Local Institution - 0062	Salt Lake City	Utah
United States	Local Institution - 0066	San Francisco	California
United States	Local Institution - 0045	Scottsdale	Arizona
United States	Local Institution - 0065	Seattle	Washington
United States	Local Institution - 0063	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Denmark,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of treatment-emergent adverse events and serious adverse events		252 weeks

External Links

•   BMS Clinical Trial Information