Health TrialsbyHealthPanel

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

ConditionsErosive EsophagitisHeartburnSymptomatic Non-erosive Gastroesophageal Reflux DiseaseHelicobacter Pylori Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-50
SponsorPhathom Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study aims to enroll a total of 728 pregnant women in the study population from the United States, with 364 women in each cohort. This sample size will afford the study the ability to detect a 3-fold increase in the prevalence of the primary outcome, MCM, in the exposed cohort with 80% power.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Vonoprazan

    Drug

    Oral tablet.

Treatment groups

728 Participants
are divided into 2 treatment groups
Group A: Exposed Cohort1 intervention
Group B: Unexposed Cohort0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

Number of Participants who Experience Spontaneous Abortion (SAB)

Time frame
DOC to 19 gestational weeks
3

Number of Participants who Experience Stillbirth

Time frame
20 gestational weeks to pregnancy outcome (approximately 40 weeks)
4

Number of Participants who Experience Elective Termination

Time frame
DOC to pregnancy outcome (approximately 40 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phathom Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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