drugset / Trial / NCT03343431
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
Phase 3
Active not recruiting
504 enrolled
Research Institute for Development
Chiang Mai University · collabMinistry of Health, Lao PDR · collabMinistry of Health, Thailand · collab
NaSingle-groupOpen-labelPrevention
Summary
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
Timeline
- Start
- 2018-08-02
- Primary completion
- 2023-05-13
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |