A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: Mavacamten

• Registration Number: NCT06146660
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-11-27
• Study Start: 2024-07-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adult participants 19 years of age or older
• Participants who receive mavacamten according to the approved product label
• Participants who sign the informed consent form

Exclusion Criteria

• Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
• Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving mavacamten for oHCM	Mavacamten	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 12 months

Trial Locations

Locations (2)

Local Institution - 0001; 🇰🇷 Seoul, Korea, Republic of

Novotech Laboratory Korea Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of