Multicenter Study To Evaluate The Efficacy Of Silymarin In Addition To Combination-Therapy With Pegylated Interferon Alfa 2a (Peg-Ifn Alfa 2a) And Ribavirin In Patients With Chronic Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- viral response at week 24
研究概览
简要总结
By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).
详细描述
Since the publication of the first data the optimal dosing schedule is investigated
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonresponders to full dose PEG-IFN/RBV therapy
- •Liver biopsy within the last 2 year
排除标准
- •Intolerance to one of the study drugs
- •Coinfection with HIV/HBV
研究组 & 干预措施
on treatment nonresponders
naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24
干预措施: Silibinin (Drug)
Nonresponders to previous antiviral combination therapy
Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy
干预措施: Silibinin (Drug)
结局指标
主要结局
viral response at week 24
时间窗: week 24
次要结局
- Safety(week 72)
- sustained virologic response(week 72)
研究者
Peter Ferenci
Prof. of Medicine
Medical University of Vienna