NCT01423708Unknown2 期
Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato
Azienda Ospedaliera di Padova7 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 117
- 试验地点
- 7
- 主要终点
- Biopsy-proven rejection episodes (BPAR)
研究概览
简要总结
Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.
详细描述
This prospective study was designed to evaluate the feasibility and effectiveness of the use of Everolimus in the minimization and possible suspension of calcineurin inhibitors in adult liver transplant patients. The study will take into account a control group (standard immunosuppression with tacrolimus and steroids) after induction with anti-IL2 Antibodies.
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
- •Male or female patients between 18 and 70 years of age,
- •Patients undergoing de novo liver transplantation from cadaveric donor with a functional graft at the time of randomization,
- •Transplantation from cadaveric donor whole or split liver,
- •Patients able to communicate properly with the study investigators, to understand and respond to the needs of the protocol and who have given written consent
- •Cold ischemia time <12 hours
排除标准
- •Physical or laboratory abnormalities or mental illness within 2 weeks before randomization such that, in the opinion of the investigator, may interfere with participation in the study
- •Women who are pregnant (positive test with hCG values> 5mUI/ml) or breast-feeding
- •Women of childbearing potential, with the following exceptions: a) women in menopause (spontaneous amenorrhea for at least 12 months, spontaneous amenorrhea for at least 6 months with FSH levels >40 mIU/ml, surgical bilateral oophorectomy at least 6 weeks before baseline, with or without hysterectomy) b) women who use one or more reliable and approved methods of contraception for the duration of the study and for the three months following discontinuation of study treatment.
- •Patients who undergo transplantation or multivisceral transplantation of pancreatic islets, or who have previously undergone organ transplantation or tissue.
- •Patients who undergo combined liver-kidney transplantation
- •Patients who undergo living donor liver transplantation
- •Patients who undergo ABO-incompatible liver transplantation
- •Patients who undergo transplantation from donors positive for HBV surface antigen or HIV
- •History of malignant disease at any site in the 3 year period prior, regardless of whether or not there is evidence of recurrence or metastasis. (Except non-metastatic skin cancers such as basal cell or squamous cell carcinoma of the skin, or hepatocellular carcinoma)
- •Patients receiving other investigational drugs within 4 weeks before baseline or who are currently enrolled in other clinical trials
- •Patients who show hypersensitivity to the drug (or drugs similar to Everolimus - Former macrolides) or class or pharmaceutical excipients. Also, when there are contraindications
- •A history of coagulopathy or the presence of any medical condition that requires long-term anticoagulant therapy after transplantation (The use of low-dose ASA is admissible)
- •Platelet count <=40.000/mm3 or WBC count <2000/mm3 or hemoglobin <=7g/dl at the time of randomization
- •Severe systemic infections
- •High cholesterol levels (>350mg/dl) or severe hypertriglyceridemia (>500mg/dl). Patients with compensated hyperlipidemia are eligible.
- •Diagnosis of pre-transplant autoimmune liver disease (PBC, sclerosing cholangitis)
- •Acute Liver Failure
研究组 & 干预措施
Everolimus
Experimental
Administration of Everolimus in association with Tacrolimus and steroids.
干预措施: Everolimus (Drug)
结局指标
主要结局
Biopsy-proven rejection episodes (BPAR)
时间窗: 3 months
Graft survival
时间窗: 3 months
Patient post-Liver Transplantation survival
时间窗: 3 months
Everolimus monotherapy
时间窗: 30 days
Patients not requiring calcineurin inhibitors (CNI)
次要结局
- Renal function evaluation(24 months)
- Requests for dialysis(24 months)
- Incidence of Adverse Events(24 months)
研究者
Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Azienda Ospedaliera di Padova
研究点 (7)
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