NCT00693524已完成2 期
An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Incidence of first acute rejection
研究概览
简要总结
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years
排除标准
- •Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
- •Recipient of an auxiliary graft or in which a bio-artificial liver has been used
- •Patient is receiving a living related liver transplantation
- •Patient is requiring steroids as well as chemotherapy prior to transplantation
- •Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
- •> 3 nodes
- •No node larger than 5 cm
- •No metastases
- •No vascular invasion
研究组 & 干预措施
1
Experimental
Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil
干预措施: tacrolimus (Drug)
1
Experimental
Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil
干预措施: Anti-IL2R AB (Drug)
1
Experimental
Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil
干预措施: Mycophenolate mofetil (Drug)
2
Active Comparator
Tacrolimus + Steroid
干预措施: tacrolimus (Drug)
2
Active Comparator
Tacrolimus + Steroid
干预措施: prednisone (Drug)
结局指标
主要结局
Incidence of first acute rejection
时间窗: 3 months
次要结局
- Overall frequences of acute rejection episodes(3 months)
研究者
相似试验
Unknown
3 期
Efficacy and Safety of Sirolimus in Combination With TacrolimusKidney TransplantationNCT00141804University Hospital Muenster190
终止
4 期
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXRKidney TransplantationKidney Transplant RejectionNCT04773392University of Southern California20
招募中
不适用
Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia GravisMyasthenia GravisNCT04768465Da, Yuwei, M.D.160
已完成
4 期
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant RecipientsLiver TransplantationNCT01551212Novartis Pharmaceuticals339
已完成
不适用
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)Lupus NephritisNCT00298506Nanjing University School of Medicine120