drugset / Trial / NCT05705427
The COMBAT HBV Feasibility Trial
Phase 4
Completed
317 enrolled
University of North Carolina, Chapel Hill
Abbott · collabAlbert Einstein College of Medicine · collabDoris Duke Charitable Foundation · collabUniversité Protestant au Congo · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC). HBV-infected pregnant women will be randomized to either receive tenofovir or placebo beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Women will be followed every 4-6 weeks throughout the prenatal and postpartum period to evaluate for side effects related to the medication. Infants will receive a birth-dose of HBV vaccine, ideally within 24 hours. Participants will be followed longitudinally through 6 months' postpartum.
Timeline
- Start
- 2023-08-17
- Primary completion
- 2025-11-25
- Completion
- 2025-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Background | Engerix-B | Vaccine | — | — |