Erosive EsophagitisNCT06660342
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
An observational study of Erosive Esophagitis and Heartburn, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease
- What is being tested?
- Vonoprazan
- Type of treatment
- Pill or oral medicine
- How many people
- 728 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to Sep 2034
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PPD
Wilmington, North Carolina, 28401
About this study
Official title: 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.
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection
- Being tested
- Vonoprazan
- Keywords
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection, Pregnant Women, Fetal, Infant
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Exposed Cohort | Pregnant women who are exposed to vonoprazan during pregnancy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Major Congenital Malformations (MCMs)
Measured: 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
Measured: 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)
Measured: DOC to 19 gestational weeks
Number of Participants who Experience Stillbirth
Measured: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Elective Termination
Measured: DOC to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Preterm Birth
Measured: DOC to 36 gestational weeks
Number of Participants who are Small for Gestational Age (SGA)
Measured: At delivery of live birth (approximately 40 weeks)
Number of Participants who Experience Postnatal Growth Deficiency
Measured: 4 Months and 12 Months from Birth
Number of Participants who Experience Infant Developmental Delay
Measured: 4 Months and 12 Months from Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 May 2025
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 728 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Phathom Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660342
- Sponsor's protocol ID
- VONO-402
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No