Hypertrophic Cardiomyopathy Clinical Trial

Mavacamten Pregnancy Surveillance Program

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Hypertrophic Cardiomyopathy

Estimated Enrollment:

20

Study ID:

NCT05939700

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There is 1 Location for this study

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The Mavacamten Pregnancy Surveillance Program, PPD Inc
Wilmington North Carolina, 28401, United States More Info
The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc
Contact
877-390-2852
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Estimated Enrollment:

20

Study ID:

NCT05939700

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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