CompletedPhase 3

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

China40 participantsStarted 2023-11-14

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patient incidence of reported adverse events (AEs)

Timeframe: Baseline to End of study, up to 2 years

Patient incidence of reported serious adverse events (SAEs )

Timeframe: Baseline to End of study, up to 2 years

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

Timeframe: Baseline to End of study, up to 2 years

Trial details

NCT IDNCT06116968

SponsorCorxel Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-20

View on ClinicalTrials.gov More Obstructive Hypertrophic Cardiomyopathy trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patient incidence of reported adverse events (AEs)

Timeframe: Baseline to End of study, up to 2 years

Patient incidence of reported serious adverse events (SAEs )

Timeframe: Baseline to End of study, up to 2 years

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

Timeframe: Baseline to End of study, up to 2 years