A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Recruiting now

Conditions studied: Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT06660342

Run by

Phathom Pharmaceuticals, Inc.

People needed

728

Starts

2025-05-15

Expected to finish

2034-09-01

Last updated by the study team

2025-05-22

Who can join

Age: 15 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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