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

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

Not Recruiting
18-85 years
All
Phase 3

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Completion of a Cytokinetics trial investigating CK-3773274
  2. LVEF ≥55% at the Screening Visit

Exclusion Criteria:

  1. Has participated in another investigational device or drug study or received an investigational device or drug <1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
  2. Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days.
  3. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
  4. Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with aficamten.
  5. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
  6. Has received treatment with mavacamten.

Study details
    Obstructive Hypertrophic Cardiomyopathy

NCT06116968

Corxel Pharmaceuticals

30 January 2026

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