Mavacamten Pregnancy Surveillance Program

Recruiting

• Conditions: Breastfeeding; Hypertrophic Cardiomyopathy; Pregnancy Related
• Interventions: Drug: Mavacamten

• Registration Number: NCT05939700
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Status Verified: 2023-11
• Study Start: 2023-11-19
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Mavacamten	Pregnant or breastfeeding women exposed to mavacamten

Primary Outcome Measures

Name	Time	Method
Pregnancy outcomes	Up to 10 months	(1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications
Fetal/neonatal/infant outcomes	Up to 12 months post pregnancy outcome	Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency

Trial Locations

Locations (1)

The Mavacamten Pregnancy Surveillance Program, PPD Inc; 🇺🇸 Wilmington, North Carolina, United States