Mavacamten Pregnancy Surveillance Program
Overview
- Phase
- N/A
- Intervention
- Mavacamten
- Conditions
- Breastfeeding
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pregnancy outcomes
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first)
- •At least 15 years of age or older at the time of enrollment
- •Informed consent or institutional review board/ethics committee-approved waiver of informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Pregnant or breastfeeding women exposed to mavacamten
Intervention: Mavacamten
Outcomes
Primary Outcomes
Pregnancy outcomes
Time Frame: Up to 10 months
(1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications
Fetal/neonatal/infant outcomes
Time Frame: Up to 12 months post pregnancy outcome
Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency