drugset / Trial / NCT04998838
Stop Hep B @ Birth
NaSingle-groupOpen-labelPrevention
Summary
Single arm, prospective open-label study of a care model consisting of two components: Component I aims to achieve high coverage of interventions to prevent maternal-to-child transmission of hepatitis B virus: antenatal tenofovir, and timely newborn administration of hepatitis B birth dose vaccine and hepatitis B immune globulin; Component II aims to achieve high coverage of screening, vaccination, and anti-viral therapy for HBV among household members of women with chronic HBV infection.
Timeline
- Start
- 2018-07-01
- Primary completion
- 2021-12-30
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HBV birth dose vaccine | Vaccine | — | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Subject | hepatitis B immune globulin | Protein / enzyme biologic | — | — |