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Reducing Vertical Transmission of Hepatitis B in Africa
Sponsor: University of Alabama at Birmingham
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 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
Key Details
Gender
FEMALE
Age Range
16 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2021-09-03
Completion Date
2026-12-31
Last Updated
2025-10-08
Healthy Volunteers
No
Conditions
Interventions
Tenofovir Disoproxil Fumarate
oral TDF medication 300 mg daily
Lamivudine Oral Solution
Oral lamivudine with weight-based dosing BID from birth until 6 months of age
Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States