RecruitingNCT05939700
Mavacamten Pregnancy Surveillance Program
Sponsor
Bristol-Myers Squibb
Enrollment
20 participants
Start Date
Nov 9, 2023
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 15 Years
Inclusion Criteria3
- 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 Criteria1
- \- None
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Interventions
DRUGMavacamten
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05939700
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