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

Last updated: May 21, 2025
Sponsor: Phathom Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

Vonoprazan

Clinical Study ID

NCT06660342
VONO-402
  • Ages 15-50
  • Female

Study 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

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 theregistry.

  • Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.

  • Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for whichvonoprazan may be prescribed.

Exclusion

Exclusion Criteria:

  • Occurrence of pregnancy outcome prior to first contact with the virtual researchcoordination center (VRCC) (retrospectively enrolled).

  • Exposure to known tetratogens and/or investigational medications during pregnancy.

  • Lost to follow-up.

Study Design

Total Participants: 728
Treatment Group(s): 1
Primary Treatment: Vonoprazan
Phase:
Study Start date:
May 15, 2025
Estimated Completion Date:
September 30, 2034

Connect with a study center

  • PPD

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

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