An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116968
• Other study ID #: JX01003
• Secondary ID: CTR20233249
• Status: Recruiting
• Phase: Phase 3
• Start date: November 14, 2023
• Est. completion date: March 15, 2026

Study information

• Verified date: March 2024
• Source: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Contact: Dong
• Phone: 8613512538014
• Email: Cherry.dong[@]jixingbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Drug:
• Aficamten
5-20mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM.	Patient incidence of reported adverse events (AEs); Patient incidence of reported serious adverse events (SAEs); Patient incidence of left ventricular ejection fraction (LVEF) < 40 %	through study completion, at least 1 year