Actively Recruiting
Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Led by Phathom Pharmaceuticals, Inc. · Updated on 2025-05-22
728
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety of vonoprazan exposure during pregnancy by comparing outcomes for pregnant women who take vonoprazan with those who do not but may use other treatments for similar conditions. The study focuses on maternal, fetal, and infant health, particularly monitoring for congenital malformations and various pregnancy outcomes related to erosive esophagitis, heartburn, symptomatic non-erosive gastroesophageal reflux disease, and Helicobacter pylori infection. The study includes two groups: pregnant women exposed to vonoprazan and those not exposed but possibly treated with other medications for related conditions. Vonoprazan is given as an oral tablet. Participants are observed from conception through pregnancy outcome, and infants are followed for up to 12 months after birth to assess health and development. Participants will provide consent and authorize their healthcare providers to share relevant data. Researchers will track major and minor congenital malformations, spontaneous abortion, stillbirth, elective termination, preterm birth, small gestational age at delivery, postnatal growth deficiencies, and developmental delays. Follow-up includes monitoring pregnancy outcomes and infant development for up to one year after birth, ensuring comprehensive safety evaluation over time.
CONDITIONS
Brief Title
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 15 to 50 years of age
- Currently or recently pregnant
- Consent to participate
- Authorization for her healthcare provider(s) to provide data to the registry
- Exposure to at least one dose of vonoprazan during pregnancy (exposed cohort)
- No exposure to vonoprazan but diagnosis of a condition treated by vonoprazan (unexposed cohort)
You will not qualify if you...
- Pregnancy outcome occurred before first contact with the virtual research coordination center
- Exposure to known teratogens and/or investigational medications during pregnancy
- Lost to follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - From conception to pregnancy outcome (approximately 40 gestational weeks) and up to 12 months from birth for live births
Participants who are pregnant and either exposed or unexposed to vonoprazan are observed to monitor pregnancy outcomes and infant development.
Periodic visits depending on pregnancy milestones and infant age
Trial Site Locations
Total: 1 location
1
PPD
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
V
VOQUEZNA Pregnancy Registry
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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