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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Erosive Esophagitis
Intervention / Treatment

-

Contacts and Locations

Wilmington

PPD, Wilmington, North Carolina, United States, 28401

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

15 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Phathom Pharmaceuticals, Inc.,

Study Record Dates

2034-09