RecruitingNot Applicable

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

United States728 participantsStarted 2025-05-15

Plain-language 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.

Who can participate

Age range15 Years – 50 Years

SexFEMALE

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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.

What they're measuring

Number of Participants with Major Congenital Malformations (MCMs)

Timeframe: Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births

Trial details

NCT IDNCT06660342

SponsorPhathom Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2034-09

Contact for this trial

VOQUEZNA Pregnancy Registry

1-866-609-1612 DLVOQUEZNAPregnancyRegistry@ppd.com

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