A 24 month, randomized, controlled, study to evaluate theefficacy and safety of concentration-controlled everolimusplus reduced tacrolimus compared to standard tacrolimusin recipients of living donor liver transplants

ovartis Healthcare Private Limited0 个研究点目标入组 29 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Written informed consent
•Subject aged >=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

•Subjects transplanted for acute liver failure
•HCV negative subjects 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 greater than 35 within 1 month prior to transplantation.
•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 greater 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/mmÂ³ or white blood cell count of less than 2,000/mmÂ³.

发起方

ovartis Healthcare Private Limited