Mavacamten Pregnancy Surveillance Program

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05939700
Status
Recruiting
Apply to this trial

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

First listed
Jul 11, 2023
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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