RECRUITINGOBSERVATIONAL
Mavacamten Pregnancy Surveillance Program
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
- willing to sign a consent form or institutional review board/ethics committee-approved waiver of willing to sign a consent form
Who Should NOT Join This Trial:
\- None
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Mavacamten
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Locations (1)
The Mavacamten Pregnancy Surveillance Program, PPD Inc
Wilmington, North Carolina, United States