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临床试验/NCT02044588
NCT02044588Unknown不适用

The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Hepatitis B transmission rate

研究概览

简要总结

To determine the safety of using kidney organ from hepatitis B surface antigen positive donor, the author conducted the single-center, prospective study of the use of these kidneys for recipients who have protective level of hepatitis B surface antibodies.

详细描述

The kidney transplant registry was conducted in KCMH since the year of 2000 until the present.

The inclusion criterion was:

  • All kidney allograft recipients who received at least one month after transplantation.
  • All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.

The exclusion criterion was:

  • The recipients with positive hepatitis C virus antibody.
  • The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
  • The recipients those lost to follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hepatitis B transmission rate

时间窗: January 2000 to December 2013

The hepatitis B transmission rate was determined at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 by using: * Clinical data including jaundice, hepatitis, acute liver failure. * Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT. * Radiological data of liver ultrasonography.

次要结局

  • Graft survival rate(January 2000 to December 2013)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wiwat Chancharoenthana

Division of Nephrology, Department of Medicine, Faculty of Medicine

Chulalongkorn University

研究点 (1)

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