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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05063071
Other study ID # TAF-Prophylaxis-Post Liver Tx
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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