Clinical trial NCT06660342: A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Official title: Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Erosive Esophagitis
Heartburn
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Helicobacter Pylori Infection
Keywords: Erosive Esophagitis
Heartburn
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Helicobacter Pylori Infection
Pregnant Women
Fetal
Infant
Lead sponsor: Phathom Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 728
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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.

Primary outcomes:
measure: Number of Participants with Major Congenital Malformations (MCMs)
timeFrame: Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
Secondary outcomes:
measure: Number of Participants with Minor Congenital Malformations
timeFrame: DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
measure: Number of Participants who Experience Spontaneous Abortion (SAB)
timeFrame: DOC to 19 gestational weeks
measure: Number of Participants who Experience Stillbirth
timeFrame: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)
measure: Number of Participants who Experience Elective Termination
timeFrame: DOC to pregnancy outcome (approximately 40 weeks)
measure: Number of Participants who Experience Preterm Birth
timeFrame: DOC to 36 gestational weeks
measure: Number of Participants who are Small for Gestational Age (SGA)
timeFrame: At delivery of live birth (approximately 40 weeks)
measure: Number of Participants who Experience Postnatal Growth Deficiency
timeFrame: 4 Months and 12 Months from Birth
measure: Number of Participants who Experience Infant Developmental Delay
timeFrame: 4 Months and 12 Months from Birth
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD
state: North Carolina
Study officials:
References: