EUCTR2004-004561-14-HU进行中（未招募）1 期
AN OPEN, RANDOMISED, MULTICENTRE, EXPLORATORY CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS IN COMBINATION WITH MONOCLONAL ANTI-IL2R ANTIBODIES OR STEROIDS IN HCV POSITIVE PATIENTS UNDERGOING LIVER ALLOGRAFT TRANSPLANTATION - CHASE (C Hepatitis and Steroid Elimination)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •1.Male or female patient of any race, 18 to 65 years of age.
- •2.HCV positive patient who is undergoing primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis and is receiving a liver transplant from cadaveric donor.
- •3.Female patient of child bearing potential must have a negative pregnancy test prior to enrolment and must agree to practice effective birth control during the study.
- •4.Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed by an independent person.
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Recipient of multi-organ transplant or previous organ transplant (including liver re-transplantation).
- •2.Recipient of an auxiliary graft or in whom an investigational bio-artificial liver (cell system) has been used.
- •3.Patient is receiving AB0 incompatible graft.
- •4.Patients requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment (azathioprine and/or steroids only) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed.
- •5.Patient is requiring ongoing corticosteroid therapy.
- •6.Patients with malignancies or a history of malignancy within the last 5 years, with the exception of those with basal or squamous cell carcinoma of the skin that has been treated successfully. Patients transplanted with hepatocellular carcinoma can be included if they meet the following criteria:
- •= 3 nodes
- •no node larger than 5 cm
- •no metastases
- •no vascular tumoral invasion
- •Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study.
- •7.Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- •8.Patient or donor is known to be HIV positive.
- •9.Patient is allergic or intolerant to steroids, macrolide antibiotics, tacrolimus and daclizumab or to any excipients of the study medication.
- •10.Patient is pregnant or breast-feeding.
- •11.Patient has been previously been enrolled in this study.
- •12.Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational / non-registered drug within the last 28 days before entry into this study.
- •13.Patient with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- •14.Patient is unlikely to comply with the visits scheduled in the protocol.
研究者
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