RecruitingNot Applicable

Mavacamten Pregnancy Surveillance Program

United States20 participantsStarted 2023-11-09

Plain-language 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

Age range15 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pregnancy outcomes

Timeframe: Up to 10 months

Fetal/neonatal/infant outcomes

Timeframe: Up to 12 months post pregnancy outcome

Trial details

NCT IDNCT05939700

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-04-30

Contact for this trial

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286 Clinical.Trials@bms.com

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