EUCTR2007-001776-36-IT进行中（未招募）不适用
A randomized, multicenter study, evaluating efficacy, safety, tolerability and pharmacokinetics of AEB071 combined with tacrolimus or mycophenolate mofetil (MMF) vs a tacrolimus-based control regimen in de novo liver transplant recipients - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •Ability and willingness to provide written informed consent and adhere to study regimen Male and female patients of any race, 18 years or older De novo recipients of a primary orthotopic liver transplant from a deceased donor HCV-positive and HCV-negative recipients
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Recipient criteria Prior organ/cellular transplants or of multiple organ transplants Anti-HIV-positive. Laboratory results obtained within 6 months prior to transplantation are acceptable ABO incompatible allograft MELD-score > 35 within 1 month prior to transplantation Serum creatinine of ≥ 3.0 mg/dL ( ≥ 265 μmol/L) or on renal replacement therapy > 1 week Donor criteria Donor age < 12 years Partial (split liver allograft Living donor liver transplantation) Cardiac death donors (DCD) / non-heartbeating donors HIV positive donors HCV positive donors into HCV negative recipients HBsAg positive donors Cold ischemic time of >15 hours Macrosteatosis > 50% PLS SEE PROTOC.
研究者
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