Status:
RECRUITING
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Lead Sponsor:
Phathom Pharmaceuticals, Inc.
Conditions:
Erosive Esophagitis
Heartburn
Eligibility:
FEMALE
15-50 years
Brief Summary
The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort o...
Eligibility Criteria
Inclusion Criteria:
- Women 15 to 50 years of age.
- Currently or recently pregnant.
- Consent to participate.
- Authorization for her health care provider(s) (HCP[s]) to provide data to the registry.
- Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.
- Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.
Exclusion Criteria:
- Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
- Exposure to known tetratogens and/or investigational medications during pregnancy.
- Lost to follow-up.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2034
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT06660342
Start Date
May 15 2025
End Date
September 1 2034
Last Update
May 22 2025
Active Locations (1)
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1
PPD
Wilmington, North Carolina, United States, 28401