Reducing Vertical Transmission of Hepatitis B in Africa

NCT04704024 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IRB-3000065865R01HD101545
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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 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

Keywords

perinatal infection, hepatitis B in pregnancy

Outcome Measures

Primary Outcomes (2)

• Vertical Transmission of hepatitis B Infection

  The proportion of infants with Hepatitis B surface antigen positivity (SAg+)

  6-9 months of age

• Virologic Suppression

  The proportion of women with a suppressed HBV DNA viral load (\<10 IU/mL).

  at delivery

Secondary Outcomes (11)

• In utero HBV infection

  at birth

• Maternal Adherence to TDF

  8 weeks after starting medication

• Maternal Adherence to TDF

  at delivery

• Infant Adherence to 3TC

  12 weeks after starting 3TC

• Infant Adherence to 3TC

  24 weeks after starting 3TC

Study Arms (2)

Pregnant Women - Tenofovir

EXPERIMENTAL

Women will be randomized to early initiation (enrollment at 14-28 weeks pregnant) vs standard initiation (at 28 weeks pregnant) of tenofovir disoproxil fumarate (TDF) 300 mg daily oral medication until delivery.

Drug: Tenofovir Disoproxil Fumarate

Newborn Infants - Lamivudine

PLACEBO COMPARATOR

Infants exposed to HBV at birth will be randomized to receive oral lamivudine post-exposure prophylaxis or matching placebo. Medication will be administered twice daily for 6 months.

Drug: Lamivudine Oral Solution

Interventions

Tenofovir Disoproxil Fumarate DRUG

oral TDF medication 300 mg daily

Also known as: TDF

Pregnant Women - Tenofovir

Lamivudine Oral Solution DRUG

Oral lamivudine with weight-based dosing BID from birth until 6 months of age

Also known as: 3TC

Newborn Infants - Lamivudine

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: eligible if pregnant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• prenatal clinic patient,
• age ≥16 years,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Jodie Dionne, MD, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pregnant women will be randomized in open label fashion to early or late initiation of TDF. Infants will be randomized to receive lamivudine or matching placebo.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 2x2 factorial

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: September 3, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)