An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Completion of a Cytokinetics trial investigating CK-3773274
• LVEF ≥55% at the Screening Visit
Locations
Other Locations
China
Beijing Anzhen Hospital
NOT_YET_RECRUITING
Beijing
Beijing Chao-yang Hospital, Capital Medical University
RECRUITING
Beijing
Fuwai Hospital, CAMS & PUMC
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Nanfang Hospital
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Nanchang University
RECRUITING
Jiangxi
The First Hospital of Jilin University
RECRUITING
Jilin
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Dong
Cherry.dong@jixingbio.com
8613512538014
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 44
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Corxel Pharmaceuticals