A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
← catalyst calendarNCT06660342 · readout ≤ 2,963 d
Sponsored by Phathom Pharmaceuticals, Inc. (industry) · PHAT — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
728estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-15 | actual | When the study began enrolling |
| Primary completion | Sep 2034 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2034 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Erosive Esophagitis
- Heartburn
- Symptomatic Non-erosive Gastroesophageal Reflux Disease
- Helicobacter Pylori Infection
Intervention
- Drug: Vonoprazan
Primary outcome
what the primary-completion date above is the date OFNumber 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
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