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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
Interventions1
Locations1 site
The Mavacamten Pregnancy Surveillance Program, PPD Inc
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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Actively Recruiting
SponsorBristol-Myers Squibb
Started2023-11-09
Est. completion2027-04-30
Eligibility
Age15 Years+
SexFEMALE
Locations1 site
View on ClinicalTrials.gov →
NCT05939700