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

NCT06660342 | Recruiting FDA Drug

• 1 other identifier: VONO-402
• Study Type: observational
• Target: 728
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Erosive Esophagitis; Heartburn; Symptomatic Non-erosive Gastroesophageal Reflux Disease; Helicobacter Pylori Infection; Pregnant Women; Fetal; Infant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Exposed Cohort

Pregnant women who are exposed to vonoprazan during pregnancy.

Drug: Vonoprazan

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.

Interventions

Vonoprazan DRUG

Oral tablet.

Exposed Cohort

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phathom Pharmaceuticals, Inc.: lead

Study Sites (1)

PPD

Wilmington, North Carolina, 28401, United States

RECRUITING

MeSH Terms

Conditions

Heartburn

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

VOQUEZNA Pregnancy Registry

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)