Mavacamten Pregnancy Surveillance Program

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Hypertrophic Cardiomyopathy; Breastfeeding
• Intervention / Treatment: Drug: Mavacamten

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401-3331
      • Recruiting
      • The Mavacamten Pregnancy Surveillance Program, PPD Inc
      • Contact: The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc; Phone Number: 877-390-2852; Email: camzyospregnancysurveillanceprogram@ppd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion 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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Pregnant or breastfeeding women exposed to mavacamten	Drug: Mavacamten; Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 10 months
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	Up to 12 months post pregnancy outcome

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: CV027-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes