Mavacamten Pregnancy Surveillance Program
NCT05939700 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-11-06
Summary
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
Conditions
- Breastfeeding
- Hypertrophic Cardiomyopathy
- Pregnancy Related
Interventions
- DRUG
-
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Eligibility
- Min Age
- 15 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-09
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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