Observational Study of Vonoprazan Exposure During Pregnancy

This study is looking at the safety of a medication called vonoprazan when taken by pregnant women. Vonoprazan is used to treat conditions like heartburn and acid reflux (erosive esophagitis, symptomatic non-erosive gastroesophageal reflux disease), and H. pylori infection. Researchers want to compare the health of mothers and their babies who took vonoprazan during pregnancy with those who didn't take vonoprazan but had similar conditions. The main goal is to see how many babies have major birth defects (major congenital malformations) in both groups. You can join if you are a woman between 15 and 50 years old, are currently or recently pregnant, and agree to share your health information. The study aims to include 728 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information from participants rather than giving them a specific treatment. It aims to enroll 728 women.
What's involved
You would need to consent to participate and authorize your healthcare provider(s) to share your health data with the study.
Compensation
Not stated in the trial record.
Follow-up
The study will track major birth defects from the date of conception until pregnancy outcome for fetal losses, or for 12 months after birth for live births.

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NCT06660342

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

Recruiting
Not specifiedAges 15–50Observational
Phathom Pharmaceuticals, Inc.
~728 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:Vonoprazan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Major Congenital Malformations (MCMs)
Measured over Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
Erosive Esophagitis
Heartburn
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Helicobacter Pylori Infection
1 sites across 1 states
North Carolina1

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Eligibility criteria

Inclusion

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

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.
  • Number of Participants with Major Congenital Malformations (MCMs)Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births