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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Breastfeeding
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Pregnancy Related

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