NCT06660342 A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
| NCT ID | NCT06660342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Phathom Pharmaceuticals, Inc. |
| Condition | Erosive Esophagitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 728 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2034-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 728 participants in total. It began in 2025-05-15 with a primary completion date of 2034-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06660342 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 50 Years, studying Erosive Esophagitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06660342 currently recruiting?
Yes, NCT06660342 is actively recruiting participants. Contact the research team at DLVOQUEZNAPregnancyRegistry@ppd.com for enrollment information.
Where is the NCT06660342 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT06660342 clinical trial?
NCT06660342 is sponsored by Phathom Pharmaceuticals, Inc.. The trial plans to enroll 728 participants.