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临床试验/NCT02894554
NCT02894554终止4 期

A Single-Center, Open-Label Study to Evaluate the Renal Function Improvement in Lamivudine Long Term Used HBsAg Positive Kidney Transplantation Patients After Switch to Telbivudine Treatment.

National Taiwan University Hospital0 个研究点目标入组 19 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
19
主要终点
To evaluate the renal function in HBsAg positive kidney transplant patients in Telbivudine and Lamivudine treatment groups by eGFR at 48 Weeks after treatment using MDRD formula.

研究概览

简要总结

The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Due to viral replication in asymptomatic HBV carriers induced by post-transplant immunosuppression, liver-related complications, such as liver failure and bleeding, account for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.

Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal allograft recipients has significantly improved patient survival rates during short-term follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine treatment.

However, limited results were known about the renal function affected by oral anti-HBV drugs when patients received kidney transplantation. Therefore, we would like to conduct this study to evaluate the renal function of Lamivudine long term used HBsAg positive patients received kidney transplantation after switch to Telbivudine treatment. The clinical and virological outcomes will provide valuable insights of clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney transplant patients who are treated with Lamivudine over 6 months (Considering include post kidney transplantation > 6 months with stable calcineurin inhibitors level
  • Seropositive of HBsAg for 6 months
  • Willing and able to provide written informed consent

排除标准

  • Hepatitis cirrhosis patients
  • Co-infection with hepatitis C virus or HIV
  • Pregnant or nursing
  • YMDD resistant at baseline
  • ABO incompatible renal transplantation
  • Cross match positive
  • Poor renal function at baseline (eGFR<20)
  • Known hypersensitivity or intolerance to any of the ingredients in Telbivudine
  • Known history of Telbivudine resistance

研究组 & 干预措施

lamivudine

Placebo Comparator

HBsAg (+) patients received renal transplant and under lamivudine therapy.

干预措施: Lamivudine (Drug)

telbivudine

Active Comparator

HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later.

干预措施: Telbivudine (Drug)

结局指标

主要结局

To evaluate the renal function in HBsAg positive kidney transplant patients in Telbivudine and Lamivudine treatment groups by eGFR at 48 Weeks after treatment using MDRD formula.

时间窗: 48 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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