Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
PPD
RECRUITING
Wilmington
Contact Information
Primary
VOQUEZNA Pregnancy Registry
DLVOQUEZNAPregnancyRegistry@ppd.com
1-866-609-1612
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2034-09
Participants
Target number of participants: 728
Treatments
Exposed Cohort
Pregnant women who are exposed to vonoprazan during pregnancy.
Unexposed Cohort
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.
Sponsors
Leads: Phathom Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov