NCT00719745已完成3 期
A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Liver Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Event rate of patients with biopsy-proven acute rejections
研究概览
简要总结
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.
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
- •Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
- •Patients who need liver transplantation due to the end-stage liver failure
排除标准
- •Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
- •Patients receiving auxiliary graft or in whom a bio-artificial
- •Patients allergic to macrolide antibiotics or tacrolimus
- •Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) 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
- •Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
- •Patients with systemic infection requiring treatment, except viral hepatitis
- •Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- •Patients with serum creatinine > 1.5mg/Dl
- •Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
- •Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
- •Patients who are pregnant or breast-feeding mother
- •Patients or donors known to be HIV positive
- •Patients unlikely to comply with the visits scheduled in the protocol
研究组 & 干预措施
1
Active Comparator
干预措施: Prograf (Drug)
2
Experimental
干预措施: MR4 (Drug)
结局指标
主要结局
Event rate of patients with biopsy-proven acute rejections
时间窗: 24 weeks
次要结局
- Incidence of and time to acute rejections and corticosteroid resistant acute rejections(12 and 24 weeks)
- Severity of biopsy-proven acute rejections.(24 weeks)
- Patient and graft survival(12 and 24 weeks)
- Incidence of adverse events(Throughout trial)
研究者
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