JPRN-jRCT2080222301已完成3 期
A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan.
ovartis Pharma K.K.0 个研究点目标入组 280 人开始时间: 2013年11月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •-Written informed consent
- •-Subject aged more than or equal to 18 years of a primary, orthotopic liver allograft, from a living donor
- •-Subject negative for HIV
- •Inclusion criteria at Randomization:
- •-Subject was initiated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression
- •Long term extension for patients in Japan:
- •-Written informed consent must be obtained before any extension specific assessment is performed.
- •-Ability and willingness to adhere to study regimen.
- •-Completed Month 24 visit of core study and continuously being treated with assigned regimen.
排除标准
- •-Subjects transplanted for acute liver failure
- •-HCV negativesubjects receiving a transplant from HCV positive donor
- •-Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant.
- •-Subjects receiving an ABO incompatible allograft.
- •-MELD-score more than 35 within 1 month prior to transplantation.
- •-Use of immunosuppressive or antibody induction agents not specified in the protocol.
- •-History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin)
- •-Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion
- •-Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks of the last dose of study medication
- •-History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients
- •Exclusion criteria at Randomization:
- •-Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic artery, major/reconstructed hepatic vein, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
- •-Subjects with a confirmed spot urine protein/creatinine ratio that indicates more than or equal to 1.0 g/24 hrs of proteinuria
- •-Subjects who have severe hypercholesterolemia (more than 350 mg/dL; more than 9 mmol/L) or hypertriglyceridemia (more than 500 mg/dL; more than 8.5 mmol/L) at randomization.
- •-Subjects with platelet count less than 30,000/mm3.
- •-Subjects with an absolute neutrophil count of less than 1,000/mm3 or white blood cell count of less than 2,000/mm3.
- •-Subjects with systemic infection requiring active use of IV antibiotics.
- •-Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents.
- •-Subjects who require renal replacement therapy within 7 days prior to randomization.
- •-Subjects with detectable HBV DNA at time of randomization
- •-Subjects meeting the following criteria for acute rejection during the run in period:
- •-Any acute rejection in the week prior to randomization.
- •-2 treated acute rejections.
- •-Any rejection requiring antibody treatment.
- •-Any severe cellular (and/or any humoral) rejection. Other protocol-defined inclusion/exclusion criteria may apply.
- •Long term extension for patients in Japan:
- •-Use of medication that is prohibited by the study protocol at Month 24.
- •-Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •-History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients
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