Clinical trial NCT05063071: Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant
Official title: Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HBV
POST LIVER TRANSPLANT
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: HBV DNA undetectable rate at week 48.
timeFrame: 48 weeks
Secondary outcomes:
measure: HBV DNA undetectable rate at week 96
timeFrame: 96 weeks
measure: HBsAg negative rate at week 48
timeFrame: 48 weeks
measure: HBsAg negative rate at week 96
timeFrame: 96 weeks
measure: ALT normalization rate at week 48
timeFrame: 48 weeks
measure: ALT normalization rate at week 96
timeFrame: 96 weeks
measure: Changes in Serum Creatinine at week 48
timeFrame: 48 weeks
measure: Changes in Serum Creatinine at week 96
timeFrame: 96 weeks
measure: Changes in eGFR (MDRD) at week 48
timeFrame: 48 weeks
measure: Changes in eGFR (MDRD) at week 96
timeFrame: 96 weeks
measure: Changes in β2-MG:Cr at week 48
timeFrame: 48 weeks
measure: Changes in β2-MG:Cr at week 96
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jian Zhou
role: PRINCIPAL_INVESTIGATOR
References: