EUCTR2010-024527-25-IT进行中（未招募）1 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 - Not applicable
ovartis Farma SpA0 个研究点目标入组 470 人开始时间: 2013年5月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Subject aged =18 years of a primary, orthotopic liver allograft, from a living donor.
- •3. Subject negative for HIV (result obtained 6 months prior to screening is acceptable).
- •4. Subject HCV and HBV status must be known.
- •5. Subject was initiated on TAC-based immunosuppressive regimen with steroids and other immunosuppression, as per protocol.
- •6. Allograft condition acceptable at time of randomization as defined by AST, ALT, total
- •Bilirubin levels =3 times ULN.
- •7. Abbreviated MDRD eGFR = 30 mL/min/1.73m2. Local serum creatinine results obtained no more than 5 d prior randomization but no sooner than 25 d post-transplantation are acceptable.
- •8. Subject must be able to take oral medication at time of randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Subjects transplanted for acute liver failure.
- •2. HCV negative subjects receiving transplant from HCV positive donor.
- •3. Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received organ or tissue transplant.
- •4. Subjects receiving ABO incompatible allograft.
- •5. MELD-score > 35 within 1 mo prior to transplantation.
- •6. Use of immunosuppressive or antibody induction agents not specified in the protocol.
- •7. History of malignancy of any organ system (except HCC or localized skin BCC), treated or untreated, within the past 5 y, regardless of evidence of local recurrence or metastases.
- •8. HCC with extrahepatic spread or macrovascular invasion.
- •9. Subjects with history of coagulopathy or medical condition requiring long-term anticoagulation precluding liver biopsy after transplantation (low dose aspirin treatment or interruption of chronic anticoagulant is allowed).
- •10. Any surgical, medical, mental conditions, other than the current transplantation, which, in the opinion of the investigator, might interfere with the objectives of the study.
- •11. Pregnant or nursing (lactating) women (pregnancy defined as state of a female after conception and until the termination of gestation, confirmed by a positive hCG test).
- •12. Women of child-bearing potential, unless using highly effective contraception methods during dosing and for 2 wks of the last dose of study medication. Highly effective contraception methods are described in the protocol.
- •13. History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients.
- •14. Use of other investigational drugs at screening, or within 30 d or 5 half-lives of screening, whichever is longer.
- •15. Subjects who are requiring the administration of strongly interacting drugs of the CYP450 3A4 system.
- •16. Full-size, split, auxiliary, dual and or/domino liver allografts.
- •17. Small-for-size allograft, defined as allograft to recipient weight ratio (GRWR) of < 0.7% or a liver volume < 30% of standard estimated volume.
- •18. HIV positive donors.
- •19. HBsAg positive donors.
- •20. Donor with hepatic steatosis > 30%.
- •21. 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. For subjects without such history Doppler confirmed absence of any hepatic vessel thrombosis or occlusion within 5 d prior to randomization, but no sooner than Day 25 post transplantation is required for randomization.
- •22. Subjects with a confirmed spot urine protein/creatinine ratio that indicates = 1.0 g/24 hrs of proteinuria and that cannot be explained by other effects.
- •23. Subjects with severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) at randomization. Subjects with controlled hyperlipidemia are acceptable at the time of randomization.
- •24. Subjects with platelet count < 30,000/mm3.
- •25. Subjects with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³.
- •26. Subjects with systemic infection requiring active use of IV antibiotics.
- •27. Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents.
- •28. Subjects who require renal replacement therapy within 7
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