An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
Study Details
Study Description
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, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aficamten Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg. |
Drug: Aficamten
5-20mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM. [through study completion, at least 1 year]
Patient incidence of reported adverse events (AEs) Patient incidence of reported serious adverse events (SAEs) Patient incidence of left ventricular ejection fraction (LVEF) < 40 %
Eligibility Criteria
Criteria
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.
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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.
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Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
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Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with aficamten.
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History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
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Has received treatment with mavacamten.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anzhen Hospital | Beijing | China | ||
| 2 | Beijing Chao-yang Hospital, Capital Medical University | Beijing | China | ||
| 3 | Peking University Third Hospital | Beijing | China | ||
| 4 | Sichuan Provincial People's Hospital | Chengdu | China | ||
| 5 | Nanfang Hospital | Guangzhou | China | ||
| 6 | The First Hospital of Jilin University | Jilin | China | ||
| 7 | Shengjing Hospital of China Medical University | Shenyang | China | ||
| 8 | Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | China | ||
| 9 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China | ||
| 10 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
Sponsors and Collaborators
- Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
Investigators
- Principal Investigator: Yuhui Zhang, MD, PUMCH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JX01003
- CTR20233249