Reducing Vertical Transmission of Hepatitis B in Africa

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.

Conditions

Hepatitis B Infection

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Study Overview

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Study Details

Study overview

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.

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

Reducing Vertical Transmission of Hepatitis B in Africa

Condition
Hepatitis B Infection
Intervention / Treatment

-

Contacts and Locations

Birmingham

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * prenatal clinic patient,
  • * age ≥16 years,
  • * 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
  • * active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA \>1000 IU/ML),
  • * plan to receive follow up care and deliver at study facility,
  • * capable of providing informed consent.
  • * HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
  • * known liver cirrhosis or end-stage liver disease,
  • * elevated liver enzymes (ALT \>5x upper limit of normal),
  • * elevated serum creatinine (\>1.4 mg/dl)
  • * currently taking tenofovir medication
  • * allergy or intolerance to tenofovir study medication,
  • * known fetal anomaly in the current pregnancy,
  • * clinical illness requiring hospitalization at the time of enrollment
  • * evidence of early labor at the time of enrollment.

Ages Eligible for Study

16 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

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

Study Record Dates

2026-12-31