NCT05939700Recruiting

Mavacamten Pregnancy Surveillance Program

Bristol-Myers Squibb

Start Date

11/9/2023

Completion Date

4/30/2027

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 Criteria

Age Range: 15 years to No maximum

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: \- None

Interventions

DRUG

Mavacamten

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Conditions

BreastfeedingHypertrophic CardiomyopathyPregnancy Related

Locations

The Mavacamten Pregnancy Surveillance Program, PPD Inc

Wilmington, North Carolina 28401-3331

United States

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