A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Launched by PHATHOM PHARMACEUTICALS, INC. · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called vonoprazan in pregnant women and their babies. Vonoprazan is used to treat conditions like heartburn, erosive esophagitis, and infections caused by Helicobacter pylori. The researchers want to see how mothers and their infants do when some women take vonoprazan during pregnancy compared to those who don’t take it but may use other treatments for similar conditions.

To participate in this study, women aged 15 to 50 who are currently pregnant or have recently been pregnant can apply. Participants will need to agree to share health information with the study team. The trial is currently seeking women who have taken at least one dose of vonoprazan during their pregnancy and those who have not taken it but have a diagnosis that may require treatment. Women who have experienced certain complications or taken other specific medications during pregnancy may not be eligible. If you join the study, you can expect to provide information about your health and pregnancy experiences, which will help researchers understand the effects of vonoprazan better.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.