EUCTR2010-020146-10-IT进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LEGALON SIL FOR THE TREATMENT OF HCV RECURRENCE IN STABLE LIVER TRANSPLANTED PATIENTS.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Patients with HCV recurrent chronic hepatitis after liver transplantation, not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care, SOC). - Stable (= 1 year) liver transplanted patients with HCV recurrence (as indicated by positive serum HCV-RNA, increase in transaminases, signs of graft damage according to HCV recurrence and/or presence of liver fibrosis as assessed by Fibroscan). - Patients without biochemical, clinical and/or histological suspicion of rejection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •- Patients with active hepatocellular carcinoma or other neoplasia. - Patients with active biliary tract anomalies. - Patients with a rejection episode in the 6 months preceding study inclusion. - Patients on active interferon treatment. - Patients with creatinine clearance < 50 ml.
研究者
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