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NCT Number: NCT06116968

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

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.

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Anzhen Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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.
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
  • Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with aficamten.
  • History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
  • Has received treatment with mavacamten.

Treatment and study plan

Aficamten

Drug

5-20mg

Other names: CK-3773274

Primary outcomes

  1. Patient incidence of reported adverse events (AEs)

    Time frame: Baseline to End of study, up to 2 years

  2. Patient incidence of reported serious adverse events (SAEs )

    Time frame: Baseline to End of study, up to 2 years

  3. Patient incidence of LVEF<50% & LVEF <40%

    Time frame: Baseline to End of study, up to 2 years

Secondary outcomes

  1. Peak LVOT-G at rest and with Valsalva provocation

    Time frame: Change from baseline values to week 48 at 12-week intervals;

  2. Proportion of patients with resting LVOT-G <50 mmHg

    Time frame: Change from baseline values to week 48 at 12-week intervals;

  3. Proportion of patients with resting LVOT-G <30 mmHg

    Time frame: Change from baseline values to week 48 at 12-week intervals;

  4. Proportion of patients with post-Valsalva LVOT-G <50 mmHg

    Time frame: Change from baseline values to week 48 at 12-week intervals;

  5. Proportion of patients with post-Valsalva LVOT-G <30 mmHg

    Time frame: Change from baseline values to week 48 at 12-week intervals;

  6. Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg

    Time frame: Change from baseline values to week 48 at 12-week intervals;

  7. First resting LVOT-G <50 mmHg

    Time frame: Time to the following event through last follow-up, up to 2 years.

  8. First resting LVOT-G <30 mmHg

    Time frame: Time to the following event through last follow-up, up to 2 years.

  9. First post-Valsalva LVOT-G <50 mmHg

    Time frame: Time to the following event through last follow-up, up to 2 years.

  10. First post-Valsalva LVOT-G <30 mmHg

    Time frame: Time to the following event through last follow-up, up to 2 years.

  11. First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg

    Time frame: Time to the following event through last follow-up, up to 2 years.

Sponsors and collaborators

Lead sponsor

Corxel Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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