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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-50
SponsorPhathom Pharmaceuticals, Inc.

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vonoprazan

Treatment groups

728 Participants
are divided into 2 treatment groups

Sponsors and collaborators