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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT06660342
- Acronym / sponsor ID
- VONO-402
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Phathom Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort | – | Drug: VonoprazanPregnant women who are exposed to vonoprazan during pregnancy. |
| 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanOral tablet. | Drug | Exposed Cohort |
Primary outcome
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
8 secondary outcomes
Number of Participants with Minor Congenital Malformations
Time frame: 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)
Time frame: DOC to 19 gestational weeks
Number of Participants who Experience Stillbirth
Time frame: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Elective Termination
Time frame: DOC to pregnancy outcome (approximately 40 weeks)
Number of Participants who Experience Preterm Birth
Time frame: DOC to 36 gestational weeks
Number of Participants who are Small for Gestational Age (SGA)
Time frame: At delivery of live birth (approximately 40 weeks)
Number of Participants who Experience Postnatal Growth Deficiency
Time frame: 4 Months and 12 Months from Birth
Number of Participants who Experience Infant Developmental Delay
Time frame: 4 Months and 12 Months from Birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Esophagitis and Heartburn, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VOQUEZNA Pregnancy Registry (1-866-609-1612, DLVOQUEZNAPregnancyRegistry@ppd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.