Last updated: March 4, 2024
Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Circulation Disorders
Treatment
Aficamten
Clinical Study ID
NCT06116968
JX01003
CTR20233249
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Completion of a Cytokinetics trial investigating CK-3773274
- LVEF ≥55% at the Screening Visit
Exclusion
Exclusion Criteria:
- Has participated in another investigational device or drug study or received aninvestigational device or drug <1 month (or 5 half-lives for drugs, whichever islonger) prior to screening. Other investigational procedures while participating inthis study are not permitted.
- Since completion of a previous study of aficamten has:Developed new-onset paroxysmalor permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g.,direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 daysprior 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 alcoholablation).
- Had a confirmed LVEF <40% with an associated dose interruption during participation ina prior study with aficamten.
- History of appropriate implantable cardioverter defibrillator (ICD) shock within 30days prior to screening.
- Has received treatment with mavacamten.
Study Design
Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Aficamten
Phase: 3
Study Start date:
November 14, 2023
Estimated Completion Date:
March 15, 2026
Connect with a study center
Beijing Anzhen Hospital
Beijing,
ChinaSite Not Available
Beijing Chao-yang Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
Fuwai Hospital, CAMS & PUMC
Beijing,
ChinaActive - Recruiting
Peking University Third Hospital
Beijing,
ChinaActive - Recruiting
Sichuan Provincial People's Hospital
Chengdu,
ChinaSite Not Available
Nanfang Hospital
Guangzhou,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Jiangxi,
ChinaActive - Recruiting
The First Hospital of Jilin University
Jilin,
ChinaActive - Recruiting
Shengjing Hospital of China Medical University
Shenyang,
ChinaActive - Recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan,
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaActive - Recruiting

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