Status:
RECRUITING
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
Lead Sponsor:
Corxel Pharmaceuticals
Conditions:
Obstructive Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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, includi...
Eligibility Criteria
Inclusion
- Completion of a Cytokinetics trial investigating CK-3773274
- LVEF ≥55% at the Screening Visit
Exclusion
- 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.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06116968
Start Date
November 14 2023
End Date
March 15 2026
Last Update
March 6 2024
Active Locations (12)
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1
Beijing Anzhen Hospital
Beijing, China
2
Beijing Chao-yang Hospital, Capital Medical University
Beijing, China
3
Fuwai Hospital, CAMS & PUMC
Beijing, China
4
Peking University Third Hospital
Beijing, China