Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- HBV DNA undetectable rate at week 48.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
TAF monotherapy without HBIG
The standard dose of TAF 25mg daily was used. TAF can be used on the first day after orthotopic liver transplantation. No HBIG was used before, during, or after transplantation; and therapeutic vaccination was not routinely used.
干预措施: Tenofovir Alafenamide 25 MG (Drug)
结局指标
主要结局
HBV DNA undetectable rate at week 48.
时间窗: 48 weeks
evaluate the HBV DNA undetectable rate (defined as HBV DNA \< 20 IU/mL) at week 48 after liver transplant.
次要结局
- ALT normalization rate at week 48(48 weeks)
- Changes in eGFR (MDRD) at week 48(48 weeks)
- Changes in β2-MG:Cr at week 48(48 weeks)
- HBsAg negative rate at week 96(96 weeks)
- ALT normalization rate at week 96(96 weeks)
- HBV DNA undetectable rate at week 96(96 weeks)
- HBsAg negative rate at week 48(48 weeks)
- Changes in Serum Creatinine at week 48(48 weeks)
- Changes in Serum Creatinine at week 96(96 weeks)
- Changes in eGFR (MDRD) at week 96(96 weeks)
- Changes in β2-MG:Cr at week 96(96 weeks)