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NCT05939700 Clinical Trial

Mavacamten Pregnancy Surveillance Program

Pregnancy Related Clinical Trial

Official title:
Mavacamten Pregnancy Surveillance Program

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05939700
Other study ID # CV027-014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 19, 2023
Est. completion date April 2027

Study information
Verified date November 2023
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 2027
Est. primary completion date April 2027
Accepts healthy volunteers
Gender Female
Age group 15 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States The Mavacamten Pregnancy Surveillance Program, PPD Inc Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy outcomes (1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications Up to 10 months
Primary Fetal/neonatal/infant outcomes 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 Up to 12 months post pregnancy outcome
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