Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

• Status: Active, not recruiting
• Trial end date: 2022-12-29
• Target enrollment: 0
• Participant gender: All

Summary

TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent. If the patient is hepatic Coma, the family member shall sign the written informed consent.

• ≥18 years old.

• Orthotopic liver transplant for HBV-related disease (such as HCC, DCC or liver failure). Patients were all positive for HBsAg for at least 6 months prior to liver transplantation.

• HBV DNA ≤ 2000 IU/mL before orthotopic liver transplant . (Including patients who received or did not receive oral antiviral therapy before liver transplantation)

Exclusion Criteria:

• Post OLT patients received HBIG

• Other solid organs transplant recipients

• HCV, HDV or HIV coinfection

• Other primary end-stage liver diseases (PBC, PSC, etc)

• Patients with underwent liver re-transplantation

• Liver grafts from HBsAg+ donors

• Graft dysfunction of any other causes

• HCC with primary portal vein thrombus