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NCT Number: NCT06660342

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

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.

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Key information

Conditions

Erosive Esophagitis Heartburn Helicobacter Pylori Infection Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Symptomatic Non-erosive Gastroesophageal Reflux Disease

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

PPD

Wilmington, North Carolina, 28401, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vonoprazan

Drug

Oral tablet.

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)

  5. Number of Participants who Experience Preterm Birth

    Time frame: DOC to 36 gestational weeks

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

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

  7. Number of Participants who Experience Postnatal Growth Deficiency

    Time frame: 4 Months and 12 Months from Birth

  8. Number of Participants who Experience Infant Developmental Delay

    Time frame: 4 Months and 12 Months from Birth

Study contacts

Contact information is provided by the study sponsor or research team.

VOQUEZNA Pregnancy Registry

CONTACT

[email protected]

1-866-609-1612

Sponsors and collaborators

Lead sponsor

Phathom Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2034
Study completion
2034
First posted
Oct 28, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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