Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

Conditions

• Symptomatic Hypertrophic Cardiomyopathy (HCM)

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Aficamten (5 - 20 mg) — DRUG
  Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.

Study Details

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Key Dates

Start date

May 6, 2021

Status verified

Jan 2025

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

900 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Aficamten up to 20 mg
  Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.

Primary Outcome Measure

Incidence of adverse events observed during dosing of aficamten in patients with HCM [ Time Frame: Baseline to End of study, up to 5 years ]

Locations (52)

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