drugset / Trial / NCT04703465

Tenofovir Alafenamide for HBV Prophylaxis in HBV(-) Liver Transplant Recipients With HBcAb+ Donors

NCT04703465

Unknown 30 enrolled RenJi Hospital
NaSingle-groupOpen-labelPrevention

Summary

Liver transplantation is currently the only effective way to treat end-stage liver disease.The shortage of donor liver is still the major problem. Incidence of HBcAb+ varies between different regions. The HBcAb positive rate could be as high as 52% in China.HBcAb positive donor liver may enlarge donor pool and thus save ESLD patients. However, the use of HBcAb positive donor liver may induce HBV infection in hepatitis B negative recipient after liver transplantation. Tenofovir alafenamide (TAF) has better stability in plasma and higher liver targeting property in comparison with tenofovir (TDF), with an extra amide bond, which allows strong antiviral effect with much less doses and reducing the renal and bone injury. Our study intends to evaluate the efficacy and safety of HBV prophylaxis treatment of TAF in HBV negative patients after receiving HBcAb positive donor livers.

Timeline

Start
2021-04-01
Primary completion
2022-04-01
Completion
2024-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject tenofovir alafenamide Small molecule 25 mg Oral