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

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Phathom Pharmaceuticals, Inc.
Study ID
NCT06660342
Status
Recruiting
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Conditions

  • Erosive Esophagitis
  • Heartburn
  • Helicobacter Pylori Infection
  • Symptomatic Non-erosive Gastroesophageal Reflux Disease

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Vonoprazan — DRUG
    Oral tablet.

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
May 2025
Primary completion
Sep 30, 2034
Completion
Sep 30, 2034

Study Design

Enrollment
728 participants (estimated)

Arms

  • Arm: Exposed Cohort
    Pregnant women who are exposed to vonoprazan during pregnancy.
  • Arm: 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPDWilmingtonNorth Carolina28401-

Find similar trials in Wilmington, NC

By research site
PPD· Wilmington, NC

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