drugset / Trial / NCT04780204
Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels
Phase 4
Active not recruiting
600 enrolled
Asan Medical Center
National Evidence-Based Healthcare Collaborating Agency · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Multicenter, Open-label, Single arm Trial with Matched Historical controls. Male and female adults with compensated liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremia. To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia compared with matched historical controls.
Timeline
- Start
- 2021-08-23
- Primary completion
- 2027-01
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |