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

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

Sex: Female

Ages: 15 Years – 50 Years

Healthy volunteers: No

Enrollment: 728

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06660342). StuddyBuddy aggregates publicly available trial information.