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临床试验/EUCTR2006-004830-34-BE
EUCTR2006-004830-34-BE进行中(未招募)1 期

TACROLIMUS AND PRETRANSPLANT HIGH-DOSE R-ATG INDUCTION VS TACROLIMUS MONOTHERAPY AS TOLEROGENIC IMMUNOSUPPRESSION IN ADULT LIVER TRANSPLANTATION.AN OPEN LABEL, RANDOMISED, PROSPECTIVE AND CONTROLLED TRIAL. - TACATG

IVERSITY HOSPITALS ST LUC0 个研究点目标入组 100 人开始时间: 2006年9月11日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • One hundred adult patients will be enrolled.
  • 1. The patient (male or female) must not be less than 15 years of age
  • 2. Post-mortem or living donor liver allograft recipients undergoing their first transplantation
  • 3. If female of childbearing potential, the patient must have practiced a medically approved form of contraception for a minimum of 30 days prior to study entry, and must continue to do so for the duration of the study treatment.
  • 4. The patient or his/her guardian must voluntarily sign an Ethics Committee-approved informed consent form for entry into this study after the contents of that document have been fully explained
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1) Patients undergoing liver allograft re-transplantation
  • 2) Patients who have undergone a previous organ transplantation
  • 3) Patients with advanced (stage III – IV – VICC) neoplastic disease.
  • 4) Patients with ABO incompatibility to the donor
  • 5) Patients with autoimmune hepatitis
  • 6) Patients who have received an investigational drug within 30 days of entry into this trial

研究者

发起方
IVERSITY HOSPITALS ST LUC

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