drugset / Trial / NCT02862548
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.
Timeline
- Start
- 2016-09-16
- Primary completion
- 2018-02-08
- Completion
- 2021-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |
| Comparator | Entecavir | Small molecule | — | — |
| Comparator | Lamivudine | Other / unclassified | — | — |
| Comparator | immunoglobulin antihepatitis B | Unknown | — | — |