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
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