Preventing Hepatitis B transmission from mothers to newborns 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
This study is testing if giving antiviral medications to pregnant women with hepatitis B can help prevent the virus from being passed to their newborns in Africa.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04704024 on ClinicalTrials.gov |
What this trial studies
The REVERT-B trial aims to evaluate the effectiveness of antiviral medications in preventing the transmission of hepatitis B from pregnant women to their newborns in Africa. This phase III, multi-center, randomized study will involve 450 pregnant women with hepatitis B, who will be assigned to different treatment groups to receive either early or standard maternal prophylaxis with Tenofovir Disoproxil Fumarate (TDF) and neonatal prophylaxis with Lamivudine. The study will assess the rates of mother-to-child transmission (MTCT) of hepatitis B, as well as the safety and adherence to the medications. Participants will be monitored until 6-9 months postpartum to evaluate the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 16 years and older, between 14-32 weeks of gestation, who are HBsAg+ and at high risk for vertical transmission of hepatitis B.
Not a fit: Patients who are HIV positive, have liver cirrhosis, or are currently taking tenofovir medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of hepatitis B transmission from mothers to their infants, improving health outcomes for newborns.
How similar studies have performed: Other studies have shown success with antiviral prophylaxis in preventing mother-to-child transmission of hepatitis B, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Jodie Dionne, MD, MSPH — University of Alabama at Birmingham
- Study coordinator: Jodie Dionne, MD, MSPH
- Email: jdionne@uabmc.edu
- Phone: 2059756530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.