Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in HBV Negative Recipients Received Orthotopic Liver Transplant With HBcAb+ Donors
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- De novo HBV infected rate after liver transplantation at 48 weeks
研究概览
简要总结
Liver transplantation is currently the only effective way to treat end-stage liver disease.The shortage of donor liver is still the major problem. Incidence of HBcAb+ varies between different regions. The HBcAb positive rate could be as high as 52% in China.HBcAb positive donor liver may enlarge donor pool and thus save ESLD patients. However, the use of HBcAb positive donor liver may induce HBV infection in hepatitis B negative recipient after liver transplantation. Tenofovir alafenamide (TAF) has better stability in plasma and higher liver targeting property in comparison with tenofovir (TDF), with an extra amide bond, which allows strong antiviral effect with much less doses and reducing the renal and bone injury. Our study intends to evaluate the efficacy and safety of HBV prophylaxis treatment of TAF in HBV negative patients after receiving HBcAb positive donor livers.
详细描述
We intent to enroll 30 patients who are HBV negative but received HBcAb+ liver. Antiviral treatment with TAF(25mg/d,oral) will be started on the first day after liver transplantation. Post-operative HBV infection is defined with positive HBV marker (HBsAg) and/or positive HBV DNA after liver transplantation. Primary outcome will be evaluated at 48 weeks. All the patients will be followed up for another at least 1 year to evaluate the long term efficacy and safety of TAF.
The primary endpoint is to calculate de novo HBV infection after liver transplantation when treating with TAF. Secondary endpoint is to evaluate the renal safety of TAF after liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with written informed consent.
- •Age ≥12 years old
- •HBV negative recipients (HBV DNA undetectable and HBsAg negative) receiving HBsAg-, HBcAb+ donor liver
排除标准
- •Patients underwent liver re-transplantation
- •CKD (CrCl<30 ml/min by MDRD formula)
- •HBV/HCV-related OLT
- •Other solid organs transplant recipients
- •HIV coinfection
研究组 & 干预措施
tenofovir alafenamide
tenofovir alafenamide 25mg daily for 48 weeks
干预措施: Tenofovir Alafenamide 25 MG (Drug)
结局指标
主要结局
De novo HBV infected rate after liver transplantation at 48 weeks
时间窗: 48 weeks
Primary outcome is to calculate de novo HBV infection after liver transplantation when treating with TAF.
次要结局
- 48 weeks Renal safety of TAF after liver transplantation.(48 weeks)
- 96 weeks Renal safety of TAF after liver transplantation.(96 weeks)