A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
2014年6月9日 更新者：Hoffmann-La Roche
A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients.
Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months).
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
180
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Besancon、法国、25030
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Bordeaux、法国、33076
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Caen、法国、14033
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Clichy、法国、92118
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Creteil、法国、94010
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Grenoble、法国、38043
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Lille、法国、59037
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Lyon、法国、69317
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Lyon cedex 3、法国、69437
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Marseille、法国、13385
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Montpellier、法国、34295
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Nice、法国、06202
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Paris、法国、75679
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Rennes、法国、35033
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Toulouse、法国、31059
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Villejuif、法国、94804
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- adult patients, >=18 years of age;
- recipient of a first orthotopic liver transplant.
Exclusion Criteria:
- history of organ transplants;
- patient receiving a multi-organ transplant;
- calculated creatinine clearance <=30mL/min before transplant;
- leukocyte count < 2000/mm3 at randomization;
- history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
- pregnant or breast-feeding females, or females of childbearing age not using effective contraception.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：MMF, Adjusted Dose; Tacrolimus; Corticosteroids
Participants received mycophenolate mofetil (MMF) 3 grams per day (g/d), orally (PO), twice per day (BID) with meals from Day 0 to Day 4; the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12. Participants also received tacrolimus adjusted to a target trough level of 8 to (-) 12 nanograms per milliliter (ng/mL) from Day 0 to Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 milligrams per kilogram (mg/kg), intravenously (IV), pre-operation on Day 0.
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3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.
其他名称：
Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
10-15 mg/kg IV pre-operation on Day 0
其他名称：
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有源比较器：MMF, Standard Dose; Tacrolimus; Corticosteroids
Participants received MMF 2 g/d, PO, BID with meals from Day 0 to Month 12. Participants also received tacrolimus adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 mg/kg, IV, pre-operation on Day 0; followed by 20 mg/d, PO, 4 times per day (QDS) from Day 0 through Month 1; 15 mg/d, PO, 3 times per day (TID) from the end of Month 1 through Month 2; 10 mg/d, PO, BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
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Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
10-15 mg/kg IV pre-operation on Day 0
其他名称：
2 g/d PO BID during meals from Day 0 to Month 12
其他名称：
20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant
大体时间：Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
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Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation.
Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe.
The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI).
If RAI = 0, 1, or 2, there was no evidence of rejection.
If RAI = 3, there was borderline acute rejection.
If RAI = 4 or 5, there was mild acute rejection.
If RAI = 6 or 7, there was moderate acute rejection.
If RAI = 8 or 9, there was severe acute rejection.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Graft Loss
大体时间：Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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Graft survival was defined as the time between the randomization date and the graft loss date.
Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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Graft Survival
大体时间：Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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The median time, in months, between randomization and graft loss event.
Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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Overall Survival (OS) at Month 12 - Percentage of Participants With an Event
大体时间：Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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Overall Survival at Month 12
大体时间：Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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The median time, in months, between randomization and OS event.
Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review
大体时间：Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年11月1日
初级完成 (实际的)
2011年7月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2007年10月16日
首先提交符合 QC 标准的
2007年10月16日
首次发布 (估计)
2007年10月17日
研究记录更新
最后更新发布 (估计)
2014年7月14日
上次提交的符合 QC 标准的更新
2014年6月9日
最后验证
2014年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.