NCT00043303已完成2 期
A Multicenter Study of the Safety and Anti-Fibrotic Efficacy of Interferon-Gamma 1b (Actimmune) in Patients With Severe Lever Fibrosis or Compensated Cirrhosis Due to Hepatitis C.
InterMune0 个研究点目标入组 502 人开始时间: 2001年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 主要终点
- Ishak fibrosis score
研究概览
简要总结
The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.
IFN-g 1b is not currently approved for the treatment of liver fibrosis.
详细描述
This study will evaluate the safety and tolerability of IFN-g 1b in patients with advanced liver fibrosis and cirrhosis due to hepatitis C. This study will also evaluate whether IFN-g 1b is effective in reducing the amount of fibrosis in the liver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18 to 75 years
- •Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA
- •History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated
- •Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system.
- •Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted)
- •Must meet minimum blood chemistry requirements
- •Cannot have unstable or uncontrolled thyroid disease
- •Cannot have a variety of other diseases (listed in protocol
- •Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.
排除标准
- 未提供
结局指标
主要结局
Ishak fibrosis score
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
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