ACTIVE_NOT_RECRUITING

Reducing Vertical Transmission of Hepatitis B in Africa

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Conditions

Hepatitis B Infectionperinatal infection, hepatitis B in pregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.

Official Title

A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa

Quick Facts

Study Start:2021-09-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04704024

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.

Ages Eligible for Study:16 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * prenatal clinic patient,
  2. * age ≥16 years,
  3. * 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
  4. * active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA \>1000 IU/ML),
  5. * plan to receive follow up care and deliver at study facility,
  6. * capable of providing informed consent.
  1. * HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
  2. * known liver cirrhosis or end-stage liver disease,
  3. * elevated liver enzymes (ALT \>5x upper limit of normal),
  4. * elevated serum creatinine (\>1.4 mg/dl)
  5. * currently taking tenofovir medication
  6. * allergy or intolerance to tenofovir study medication,
  7. * known fetal anomaly in the current pregnancy,
  8. * clinical illness requiring hospitalization at the time of enrollment
  9. * evidence of early labor at the time of enrollment.

Contacts and Locations

Principal Investigator

Jodie Dionne, MD, MSPH
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Jodie Dionne, MD, MSPH, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-09-03
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • perinatal infection, hepatitis B in pregnancy

Additional Relevant MeSH Terms

  • Hepatitis B Infection