Mavacamten Pregnancy Surveillance Program

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05939700
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mavacamten — DRUG
    Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding

Study Details

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.

Key Dates

Start date
Nov 9, 2023
Status verified
Nov 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Cohort 1
    Pregnant or breastfeeding women exposed to mavacamten

Primary Outcome Measure

Pregnancy outcomes [ Time Frame: Up to 10 months ]

Central Contacts

  • BMS Study Connect Contact Center www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (1)

FacilityCityStateZIPSite coordinators
The Mavacamten Pregnancy Surveillance Program, PPD IncWilmingtonNorth Carolina28401-3331
The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc
[email protected]
877-390-2852

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The Mavacamten Pregnancy Surveillance Program, PPD Inc· Wilmington, NC

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