Mavacamten Pregnancy Surveillance Program

Description

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.

Conditions

Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related

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Study Overview

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Study Details

Study overview

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.

Mavacamten Pregnancy Surveillance Program

Mavacamten Pregnancy Surveillance Program

Condition
Breastfeeding
Intervention / Treatment

-

Contacts and Locations

Wilmington

The Mavacamten Pregnancy Surveillance Program, PPD Inc, Wilmington, North Carolina, United States, 28401-3331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

15 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2027-04