Status:
ACTIVE_NOT_RECRUITING
Reducing Vertical Transmission of Hepatitis B in Africa
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hepatitis B Infection
Eligibility:
FEMALE
16-50 years
Phase:
PHASE3
Brief Summary
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 pe...
Detailed Description
The REVERT-B trial is a multi-center, phase III, randomized 2x2 factorial study designed to test the efficacy of early maternal TDF vs standard duration and neonatal 3TC prophylaxis compared to matchi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04704024
Start Date
September 3 2021
End Date
December 31 2026
Last Update
October 8 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294