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

May 21, 2025 updated by: Phathom Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

728

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • PPD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study aims to enroll a total of 728 pregnant women in the study population from the United States, with 364 women in each cohort. This sample size will afford the study the ability to detect a 3-fold increase in the prevalence of the primary outcome, MCM, in the exposed cohort with 80% power.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed Cohort
Pregnant women who are exposed to vonoprazan during pregnancy.
Drug: Vonoprazan
Oral tablet.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Minor Congenital Malformations
Time Frame: DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
Number of Participants who Experience Spontaneous Abortion (SAB)
Time Frame: DOC to 19 gestational weeks
DOC to 19 gestational weeks
Number of Participants who Experience Stillbirth
Time Frame: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)
20 gestational weeks to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Elective Termination
Time Frame: DOC to pregnancy outcome (approximately 40 weeks)
DOC to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Preterm Birth
Time Frame: DOC to 36 gestational weeks
DOC to 36 gestational weeks
Number of Participants who are Small for Gestational Age (SGA)
Time Frame: At delivery of live birth (approximately 40 weeks)
At delivery of live birth (approximately 40 weeks)
Number of Participants who Experience Postnatal Growth Deficiency
Time Frame: 4 Months and 12 Months from Birth
4 Months and 12 Months from Birth
Number of Participants who Experience Infant Developmental Delay
Time Frame: 4 Months and 12 Months from Birth
4 Months and 12 Months from Birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phathom Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

September 1, 2034

Study Completion (Estimated)

September 1, 2034

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VONO-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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