NCT01509391已完成不适用
Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1
Medical University of Graz1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Hepatitis C viral load at week 24
研究概览
简要总结
In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Hepatitis C infection
- •no previous therapy
- •at least one contraindication to interferon therapy
- •liver cirrhosis
- •age between 18-80 y
- •women of not childbearing age
排除标准
- •Hypersensitivity against keyhole-limpet hemocyanin
- •previous treatment against hepatitis c
- •autoimmune disorders
- •immunosuppression
- •hepatocellular carcinoma or other malignancies
- •coinfection with hepatitis b or HIV
- •pregnancy
- •cardiovascular event during the last 6 months (stroke or MCI)
- •uncontrolled diabetes
- •renal insufficiency (GFR < 50 ml/min) or chronic hemodialysis
研究组 & 干预措施
Keyhole-limpet hemocyanine
Experimental
干预措施: keyhole-limpet hemocyanin (Drug)
结局指标
主要结局
Hepatitis C viral load at week 24
时间窗: 24 weeks
次要结局
- Hepatitis c viral load at weeks 1,2,4,8,12,18,32(1,2,4,8,12,18,32 weeks)
研究者
Rudolf Stauber, MD
Univ. Prof. Dr.
Medical University of Graz
研究点 (1)
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