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

Phathom Pharmaceuticals

Status: Enrolling

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

Treatments: Drug: Vonoprazan

Study type: Observational

Funder types: Industry

Identifiers

NCT06660342

VONO-402

Details and patient eligibility

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.

Enrollment: 728 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

728 participants in 2 patient groups

Exposed Cohort

Description:

Pregnant women who are exposed to vonoprazan during pregnancy.

Treatment:

Drug: Vonoprazan

Unexposed Cohort

Description:

Pregnant women who are not exposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.