Long-term treatment with Aficamten for Chinese patients with obstructive hypertrophic cardiomyopathy

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

This study is testing how safe and effective the heart medication Aficamten is for Chinese patients with obstructive hypertrophic cardiomyopathy who have already tried it in a previous trial.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Corxel Pharmaceuticals (Industry-sponsored)
• Locations: 12 sites (Beijing and 11 other locations)
• Trial ID: NCT06116968 on ClinicalTrials.gov

What this trial studies

This open-label extension study focuses on Chinese patients who have completed a prior trial involving the drug Aficamten for obstructive hypertrophic cardiomyopathy (oHCM). The study aims to gather long-term safety and tolerability data, while also assessing cardiac function and pharmacokinetics during chronic dosing of Aficamten. Participants will be monitored for their heart function and overall health as they continue treatment with this medication.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese patients who have completed a previous trial involving Aficamten and have a left ventricular ejection fraction (LVEF) of 55% or higher.

Not a fit: Patients who have recently developed atrial fibrillation or have undergone septal reduction therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients suffering from obstructive hypertrophic cardiomyopathy.

How similar studies have performed: Other studies involving Aficamten have shown promise, indicating that this approach may be effective for treating oHCM.

Eligibility criteria

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.

Where this trial is running

Beijing and 11 other locations

• Beijing Anzhen Hospital — Beijing, China (Not_yet_recruiting)
• Beijing Chao-yang Hospital, Capital Medical University — Beijing, China (Recruiting)
• Fuwai Hospital, CAMS & PUMC — Beijing, China (Recruiting)
• Peking University Third Hospital — Beijing, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Not_yet_recruiting)
• Nanfang Hospital — Guangzhou, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Nanchang University — Jiangxi, China (Recruiting)
• The First Hospital of Jilin University — Jilin, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, China (Recruiting)
• Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: Yuhui Zhang, MD — Pumch
• Study coordinator: Dong

Conditions Obstructive Hypertrophic Cardiomyopathy