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

Recruiting

• Conditions: Erosive Esophagitis; Heartburn; Symptomatic Non-erosive Gastroesophageal Reflux Disease; Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan

• Registration Number: NCT06660342
• Lead Sponsor: Phathom Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Status Verified: 2025-05
• Study Start: 2025-05-15
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2034-09
• Study Completion: 2034-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 728

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed Cohort	Vonoprazan	Pregnant women who are exposed to vonoprazan during pregnancy.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Major Congenital Malformations (MCMs)	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

Name	Time	Method
Number of Participants with Minor Congenital Malformations	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)	DOC to 19 gestational weeks
Number of Participants who Experience Stillbirth	20 gestational weeks to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Elective Termination	DOC to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Preterm Birth	DOC to 36 gestational weeks
Number of Participants who are Small for Gestational Age (SGA)	At delivery of live birth (approximately 40 weeks)
Number of Participants who Experience Postnatal Growth Deficiency	4 Months and 12 Months from Birth
Number of Participants who Experience Infant Developmental Delay	4 Months and 12 Months from Birth

Trial Locations

Locations (1)

PPD; 🇺🇸 Wilmington, North Carolina, United States