HBV Clinical Trial
Official title:
Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease
Verified date | July 2021 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
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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