Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
About
Brief Summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Completion of a Cytokinetics trial investigating aficamten
- LVEF ≥ 55% at the Screening Visit
Exclusion Criteria:
- Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
- 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.
- Since completion of a previous trial of aficamten has:
- Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) < 100 bpm and/or rhythm is stable > 30 days
- Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
- Had a confirmed LVEF < 40% with an associated dose interruption during participation in a prior study with aficamten
- History of implantable ICD placement within 30 days prior to screening.
Join this Trial
Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but
only to people in that particular population, who are specifically invited to participate.
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Study Stats
Protocol No.
25-0788
Category
Heart/Cardiovascular Diseases
Principal Investigator
Jessica Wang
Contact
- Christopher Li
Location
- UCLA Westwood