Examining the safety of vonoprazan in pregnant women and their babies
Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
This study is testing whether taking vonoprazan during pregnancy is safe for both mothers and their babies by comparing outcomes between those who took the medication and those who didn’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 728 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | Female |
| Sponsor | Phathom Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT06660342 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of vonoprazan exposure in pregnant women by comparing maternal, fetal, and infant outcomes between those who have taken vonoprazan and those who have not. The study will include women aged 15 to 50 who are currently or recently pregnant, with one group having been exposed to vonoprazan and another serving as a comparison cohort. Data will be collected from healthcare providers to evaluate the effects of the medication on both mothers and their offspring.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 15 to 50 who have either been exposed to vonoprazan or are part of a comparison group that has not been exposed.
Not a fit: Patients who have experienced pregnancy outcomes prior to the study's initial contact or those exposed to known teratogens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of vonoprazan for pregnant women and their children.
How similar studies have performed: While this study focuses on a specific medication in a unique population, similar observational studies have provided valuable safety data for other medications during pregnancy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wilmington, North Carolina
- Ppd — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: VOQUEZNA Pregnancy Registry
- Email: DLVOQUEZNAPregnancyRegistry@ppd.com
- Phone: 1-866-609-1612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.