Mavacamten Pregnancy Surveillance Program

Last updated: November 22, 2023
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Congestive Heart Failure

Heart Disease

Treatment

Mavacamten

Clinical Study ID

NCT05939700
CV027-014
  • Ages > 15
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 monthsprior to conception to pregnancy outcome) and/or at any time during breastfeeding (upto 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 ofinformed consent

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Mavacamten
Phase:
Study Start date:
November 19, 2023
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • The Mavacamten Pregnancy Surveillance Program, PPD Inc

    Wilmington, North Carolina 28401-3331
    United States

    Active - Recruiting

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