Mavacamten Pregnancy Surveillance Program
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15+
SponsorBristol-Myers Squibb
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Individuals 15 years of age or older who are exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mavacamten
DrugObservational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 10 months2
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
Time frame
Up to 12 months post pregnancy outcomeSponsors and contacts
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Source ClinicalTrials.gov