Mavacamten Pregnancy Surveillance Program
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.
| Condition(s) | Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 15 Years |
| Sex | Female |
| Lead sponsor | Bristol-Myers Squibb |
| Locations | Wilmington, North Carolina, United States |
| Start date | 2023-11-09 |
| NCT ID | NCT05939700 |
| Official listing | https://clinicaltrials.gov/study/NCT05939700 |