Actively Recruiting
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Led by Phathom Pharmaceuticals, Inc. · Updated on 2025-05-22
728
Participants Needed
1
Research Sites
485 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 15 to 50 years of age
- Currently or recently pregnant
- Consent to participate in the study
- Authorization for healthcare providers to share medical data with the registry
- Exposure to at least one dose of vonoprazan during pregnancy (exposed cohort)
- No exposure to vonoprazan but diagnosed with conditions for which vonoprazan may be prescribed (unexposed cohort)
You will not qualify if you...
- Pregnancy outcome occurred before first contact with the virtual research coordination center
- Exposure to known teratogens or investigational medications during pregnancy
- Lost to follow-up during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
PPD
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
V
VOQUEZNA Pregnancy Registry
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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