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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2025-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

NCT04848506

Symptomatic Hypertrophic Cardiomyopathy (HCM)

ENROLLING_BY_INVITATION PHASE2/PHASE3

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

NCT05767346

Obstructive Hypertrophic Cardiomyopathy (oHCM)

COMPLETED PHASE3

A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT07023341

Obstructive Hypertrophic Cardiomyopathy

RECRUITING PHASE3

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM

NCT06081894

Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

ACTIVE_NOT_RECRUITING PHASE3

Aficamten vs Placebo in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (SEQUOIA-HCM)

NCT05186818

Obstructive Hypertrophic Cardiomyopathy (oHCM)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Hypertrophic Cardiomyopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Aficamten

Intervention Type DRUG

5-20mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aficamten

5-20mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CK-3773274

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No