NCT04704024Active, not recruitingPhase 3
Reducing Vertical Transmission of Hepatitis B in Africa
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 334 (actual)
- First submitted
- 7 Jan 2021
- Start date
- 3 Sept 2021
- Primary completion date
- 1 May 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Hepatitis B
- NCT number
- NCT04704024
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 334
- From 3 Sept 2021 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently taking tenofovir medication
Other illness
- HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
- known liver cirrhosis or end-stage liver disease,
- allergy or intolerance to tenofovir study medication,
- clinical illness requiring hospitalization at the time of enrollment
Lab values
- elevated liver enzymes (ALT \>150 \[5x upper limit of normal\]),
- elevated serum creatinine (\>1.4 mg/dl)
Other
- known fetal anomaly in the current pregnancy,
- evidence of early labor at the time of enrollment.
Who the study is looking for
- 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 HBV DNA \>1000 IU/ML or HbEAg+),
- plan to receive follow up care and deliver at study facility,
- capable of providing informed consent.
Age in the registry: 16 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.