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

Phathom Pharmaceuticals, Inc.728 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

728

Conditions

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

Interventions

Vonoprazan

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants with Major Congenital Malformations (MCMs)

Time frame: Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births

Secondary Outcomes

Number of Participants with Minor Congenital Malformations

Time frame: DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births

Number of Participants who Experience Spontaneous Abortion (SAB)

Time frame: DOC to 19 gestational weeks

Number of Participants who Experience Stillbirth

Time frame: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)

Number of Participants who Experience Elective Termination

Time frame: DOC to pregnancy outcome (approximately 40 weeks)

Number of Participants who Experience Preterm Birth

Time frame: DOC to 36 gestational weeks

Number of Participants who are Small for Gestational Age (SGA)

Time frame: At delivery of live birth (approximately 40 weeks)

Number of Participants who Experience Postnatal Growth Deficiency

Time frame: 4 Months and 12 Months from Birth

Number of Participants who Experience Infant Developmental Delay