Recruiting

Mavacamten

Sponsor:

Bristol-Myers Squibb

Code:

NCT05939700

Conditions

Breastfeeding

Hypertrophic Cardiomyopathy

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Mavacamten

Study Details

Brief 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.

Conditions

Breastfeeding

Hypertrophic Cardiomyopathy

Pregnancy Related

Study ID

NCT05939700

Start date

Nov 9, 2023

Status verified date

Nov, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Pregnant or breastfeeding women exposed to mavacamten

Interventions

Mavacamten

Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding

Primary outcome measure

  • Pregnancy outcomes [ Time Frame: Up to 10 months ]
  • Fetal/neonatal/infant outcomes [ Time Frame: Up to 12 months post pregnancy outcome ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

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

Locations

The Mavacamten Pregnancy Surveillance Program, PPD Inc

Recruiting

Wilmington, North Carolina, United States, 28401-3331

Contacts

The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc

877-390-2852camzyospregnancysurveillanceprogram@ppd.com

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2025-11-06.