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

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

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

Inclusion Criteria:

  1. Completion of a Cytokinetics trial investigating CK-3773274
  2. LVEF ≥55% at the Screening Visit

Exclusion

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Undergone septal reduction therapy (surgical myectomy or transcatheter alcoholablation).
  4. Had a confirmed LVEF <40% with an associated dose interruption during participation ina prior study with aficamten.
  5. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30days prior to screening.
  6. 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,
    China

    Site Not Available

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Fuwai Hospital, CAMS & PUMC

    Beijing,
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing,
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu,
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou,
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Jiangxi,
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Jilin,
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang,
    China

    Active - Recruiting

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

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