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A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Sponsor: Phathom Pharmaceuticals, Inc.
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 of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.
Official title: Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Key Details
Gender
FEMALE
Age Range
15 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
728
Start Date
2025-05-15
Completion Date
2034-09
Last Updated
2025-05-22
Healthy Volunteers
No
Conditions
Interventions
Vonoprazan
Oral tablet.
Locations (1)
PPD
Wilmington, North Carolina, United States