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临床试验/ACTRN12613000554763
ACTRN12613000554763进行中(未招募)4 期

A randomised study comparing universal valganciclovir prophylaxis with quantitative polymerase chain reaction (PCR) based preemptive therapy for cytomegalovirus (CMV) disease in renal transplant recipients.

ass. Prof. Tomas Reischig, M.D., Ph.D.0 个研究点目标入组 140 人开始时间: 2013年5月16日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Adult renal transplant candidates, complement-dependent cytotoxicity (CDC) cross-match negative at the time of transplantation, deceased (non-heart-beating donors or dual kidney transplantation are allowed) or living (both related and unrelated, AB0 compatible or incompatible) donors with known cytomegalovirus (CMV) serology before transplantation, CMV serology: donor(D)/recipient (R) serostatus of D+/R-, D+/R+, and D-/R+, ability to sign informed consent.

排除标准

  • Unknown pretransplantation CMV serology of the donor or recipient, D-/R- CMV serostatus, treatment of systemic viral infection within 2 weeks before transplantation except for active hepatitis B or hepatitis C infection, therapy with systemic antiviral agents within 2 weeks before transplantation except for treatment of hepatitis B (lamivudine, adefovir, entecavir), white blood cell (WBC) count <3.0 x 10exp9/L, platelet count <100 x 10exp9/L, allergy to ganciclovir, inclusion to another clinical trial, inability to provide informed consent.

研究者

发起方
ass. Prof. Tomas Reischig, M.D., Ph.D.

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