RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Quick Facts

Study Start:2024-10
Study Completion:2034-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06660342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women 15 to 50 years of age.
  2. * Currently or recently pregnant.
  3. * Consent to participate.
  4. * Authorization for her health care provider(s) (HCP\[s\]) to provide data to the registry.
  5. * Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.
  6. * Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.
  1. * Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
  2. * Exposure to known tetratogens and/or investigational medications during pregnancy.
  3. * Lost to follow-up.

Contacts and Locations

Study Contact

VOQUEZNA Pregnancy Registry
CONTACT
1-866-609-1612
DLVOQUEZNAPregnancyRegistry@ppd.com

Study Locations (Sites)

PPD
Wilmington, North Carolina, 28401
United States

Collaborators and Investigators

Sponsor: Phathom Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10
Study Completion Date2034-09

Study Record Updates

Study Start Date2024-10
Study Completion Date2034-09

Terms related to this study

Keywords Provided by Researchers

  • Erosive Esophagitis
  • Heartburn
  • Symptomatic Non-erosive Gastroesophageal Reflux Disease
  • Helicobacter Pylori Infection
  • Pregnant Women
  • Fetal
  • Infant

Additional Relevant MeSH Terms

  • Erosive Esophagitis
  • Heartburn
  • Symptomatic Non-erosive Gastroesophageal Reflux Disease
  • Helicobacter Pylori Infection