NCT00720408已完成3 期
A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw 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
- 48
- 主要终点
- Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- •Patient is a primary liver transplant recipient
- •Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation
- •Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
排除标准
- •Patient has previously received or is receiving an organ transplant other than a liver
- •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- •Patient has received a liver transplant from a non-heart beating donor
- •Patient has received an ABO incompatible donor liver
- •Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully
- •Patient has fulminant hepatic failure, unless hemodynamically stable
- •Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
- •Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- •Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
- •Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
- •Patient is pregnant or lactating
- •Patient is unlikely to comply with the visits scheduled in the protocol, including the protocol biopsies
- •Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator
研究组 & 干预措施
Prograf-XL + MMF
Experimental
干预措施: Prograf-XL (Drug)
Prograf-XL + MMF
Experimental
干预措施: MMF (Drug)
Prograf + MMF
Active Comparator
干预措施: Prograf (Drug)
Prograf + MMF
Active Comparator
干预措施: MMF (Drug)
结局指标
主要结局
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.
时间窗: 6 month
次要结局
- Patient and graft survival rates during the 6 and 12 months post-transplant(6 and 12 month)
- Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant(12 month)
- Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant(6 and 12 month)
研究者
相似试验
已完成
3 期
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant RecipientsKidney TransplantationTransplantation ImmunologyHost vs Graft ReactionNCT00717678Astellas Pharma Inc73
已完成
1 期
Fast & Fed Pharmacokinetic (PK) StudyBioavailabilityNCT00692016Bayer32
已完成
4 期
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation PatientsLiver TransplantationNCT01018914Astellas Pharma Inc44
已完成
3 期
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I DisorderBipolar DisorderNCT00490971Johnson & Johnson Pharmaceutical Research & Development, L.L.C.768
已完成
3 期
A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With SchizophreniaSchizophreniaNCT00650793Johnson & Johnson Pharmaceutical Research & Development, L.L.C.473