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Mavacamten Pregnancy Surveillance Program

RECRUITINGSponsored by Bristol-Myers Squibb
Actively Recruiting
SponsorBristol-Myers Squibb
Started2023-11-09
Est. completion2027-04-30
Eligibility
Age15 Years+
SexFEMALE
Locations1 site
View on ClinicalTrials.gov →

NCT05939700

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.

Eligibility

Age: 15 Years+Sex: FEMALE
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

Conditions4

BreastfeedingHeart DiseaseHypertrophic CardiomyopathyPregnancy Related

Locations1 site

The Mavacamten Pregnancy Surveillance Program, PPD Inc
Wilmington, North Carolina, 28401-3331
The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc877-390-2852camzyospregnancysurveillanceprogram@ppd.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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