drugset / Trial / NCT04704024
Reducing Vertical Transmission of Hepatitis B in Africa
Phase 3
Active not recruiting
450 enrolled
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedFactorialQuadruple-blindPrevention
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.
Timeline
- Start
- 2021-09-03
- Primary completion
- 2026-05-01
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lamivudine | Other / unclassified | — | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |