A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
NCT ID: NCT06660342
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
728 participants
OBSERVATIONAL
2025-05-15
2034-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exposed Cohort
Pregnant women who are exposed to vonoprazan during pregnancy.
Vonoprazan
Oral tablet.
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.
No interventions assigned to this group
Interventions
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Vonoprazan
Oral tablet.
Eligibility Criteria
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Inclusion Criteria
* 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
* Exposure to known tetratogens and/or investigational medications during pregnancy.
* Lost to follow-up.
15 Years
50 Years
FEMALE
No
Sponsors
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Phathom Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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PPD
Wilmington, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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VONO-402
Identifier Type: -
Identifier Source: org_study_id
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