Mavacamten Pregnancy Surveillance Program
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15+
SponsorBristol-Myers Squibb
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Mavacamten
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1The Mavacamten Pregnancy Surveillance Program, PPD Inc28401-3331, WilmingtonNorth Carolina, United States
Sponsors and collaborators
Bristol-Myers Squibb
Lead sponsor
Source ClinicalTrials.gov