NCT00451932已完成2 期
A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 29
- 主要终点
- Event rate of biopsy-proven acute rejections
研究概览
简要总结
A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients at least 18 years of age and not older than 65 years.
- •Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
- •Male patients must agree to practice effective birth control methods during the study.
- •Patient is a recipient of a primary whole cadaveric liver transplant
排除标准
- •Patient has previously received or is receiving an organ transplant other than a liver.
- •Patient has received an ABO incompatible donor liver.
- •Patient or donor is known to be HIV positive.
- •Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- •Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one > 3.0 cm.
- •Patient has a serum creatinine >175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
- •Patient who is receiving or may require warfarin or fluvastatin during the study.
- •Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant
结局指标
主要结局
Event rate of biopsy-proven acute rejections
次要结局
- Incidence of adverse events
研究者
研究点 (29)
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