KCT0000478已完成未知
A Phase IV, Single center, Open-label, Randomized Study to evaluate the Safety and Efficacy of a Tacrolimus twice daily, PROGRAF® versus a Tacrolimus Modified Release, ADVAGRAF®, in stable Liver transplant recipients taking Tacrolimus twice daily.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •A subject is eligible for the study if all of the following apply:
- •?More than 20 years of age
- •?A minimum of 12 months post liver transplant
- •?Average of tacrorimus trough level is 1-10 ng/mL for 12 weeks before screening.
- •?Female subjects of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment and at the end of study and must agree to practice effective birth control during the study.
- •?Subjects are stable clinically in the opinion of the investigator.
- •?Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study.
排除标准
- •A subject will be excluded from participation if any of the following apply:
- •?Subjects having previously received an organ transplant excluding liver transplant. Or Subjects receiving an auxiliary graft or in whom a bio-artificial liver(cell system) has been used.
- •?Acute rejection within 12 weeks before screening or acute rejection requiring anti-lymphocyte antibody therapy within 24 weeks before screening.
- •?Subjects diagnosed new malignant tumor after liver transplantation, with the exception of basalioma or squamous cell carcinoma of the skin that has been treated successfully.
- •?Subjects allergic to tacrolimus or investigational product.
- •?Subjects are unstable clinically state in the opinion of the investigator.
- •?Subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- •?Subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days.
- •?Subjects taking forbidden concomitant medications or within 28 days prior to enroll.
- •?Subjects who are pregnant or breast-feeding mother.
- •?Subjects known to be HIV positive.
- •?Subjects unlikely to comply with the visits scheduled in the protocol.
- •?Subjects with renal dysfunction or serum creatinine > 1.6mg/dL or GFR(MDRD)<30mL/min in the baseline.
- •?Hepatic dysfunction: rising more than twice the normal range of SGPT/ALT and/or SGOT/AST and/or bilirubin, hepatic cirrhosis
研究者
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