Mavacamten Pregnancy Surveillance Program

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Pregnancy Related; Breastfeeding; Hypertrophic Cardiomyopathy

Treatments: Drug: Mavacamten

Study type: Observational

Funder types: Industry

Identifiers

NCT05939700

CV027-014

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Cohort 1

Description:

Pregnant or breastfeeding women exposed to mavacamten

Treatment:

Drug: Mavacamten