An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

Sponsor
Corxel Pharmaceuticals
Study ID
NCT06116968
Phase
PHASE3
Status
Completed

Conditions

  • Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.

Key Dates

Start date
Nov 14, 2023
Status verified
Jan 2026
Primary completion
Oct 20, 2025
Completion
Oct 20, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aficamten
    Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg.

Primary Outcome Measure

Patient incidence of reported adverse events (AEs) [ Time Frame: Baseline to End of study, up to 2 years ]

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