drugset / Trial / NCT04543565
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.
Timeline
- Start
- 2020-09
- Primary completion
- 2022-10
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Subject | pradefovir | Small molecule | — | — |