Clinical trial NCT06116968: An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
Official title: An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM.
timeFrame: through study completion, at least 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Fuwai Hospital, CAMS & PUMC
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Jiangxi
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Jilin
country: China
facility: The First Hospital of Jilin University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: PUMCH
name: Yuhui Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: