Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

HBV Clinical Trial

Official title:

Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05063071
• Other study ID #: TAF-Prophylaxis-Post Liver Tx
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 29, 2021
• Est. completion date: December 29, 2022

Study information

• Verified date: July 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

LT has evolved rapidly, becoming the standard therapy for acute and chronic liver failure of a variety of aetiologies, with more than 80,000 procedures performed to date [13]. HBV infection is a worldwide public health problem, especially in China. The need for an antiviral treatment with NAs for liver transplant recipients has two objectives: the improvement of liver function and to decrease the risk of HBV recurrence after transplant. TAF, TDF and ETV are currently the first-line therapy in patients with CHB in all CHB treatment guidelines, which have a greater potency and higher barriers to resistance. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HBV
• POST LIVER TRANSPLANT

Intervention

Drug:
• Tenofovir Alafenamide 25 MG
After orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis.

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA undetectable rate at week 48.	evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 48 after liver transplant.	48 weeks
Secondary	HBV DNA undetectable rate at week 96	evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 96 after liver transplant.	96 weeks
Secondary	HBsAg negative rate at week 48	evaluate the HBsAg negative rate at week 48 after liver transplant.	48 weeks
Secondary	HBsAg negative rate at week 96	evaluate the HBsAg negative rate at week 96 after liver transplant.	96 weeks
Secondary	ALT normalization rate at week 48	evaluate the ALT normalization rate at week 48 after liver transplant.	48 weeks
Secondary	ALT normalization rate at week 96	evaluate the ALT normalization rate at week 96 after liver transplant.	96 weeks
Secondary	Changes in Serum Creatinine at week 48	evaluate the change of Serum Creatinine at week 48 after liver transplant.	48 weeks
Secondary	Changes in Serum Creatinine at week 96	evaluate the change of Serum Creatinine at week 96 after liver transplant.	96 weeks
Secondary	Changes in eGFR (MDRD) at week 48	evaluate the change of eGFR (MDRD) at week 48 after liver transplant.	48 weeks
Secondary	Changes in eGFR (MDRD) at week 96	evaluate the change of eGFR (MDRD) at week 96 after liver transplant.	96 weeks
Secondary	Changes in ß2-MG:Cr at week 48	evaluate the change of ß2-MG:Cr at week 48 after liver transplant.	48 weeks
Secondary	Changes in ß2-MG:Cr at week 96	evaluate the change of ß2-MG:Cr at week 96 after liver transplant.	96 weeks