NCT01137383已完成3 期
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Sustained viral response
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.
详细描述
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C
- •Age between 15 and 65
排除标准
- •previous treatment for chronic hepatitis C
- •co-infection with human immunodeficiency virus or hepatitis B virus
- •major thalassemia or hemophilia
- •active drug user
- •being treated for major depression or psychosis
- •decompensated cirrhosis
- •serum creatinine > 1.5 mg/dL
- •solid organ transplant
- •untreated thyroid disease
- •uncontrolled diabetes mellitus
- •uncontrolled autoimmune disease
- •advanced cardiac or pulmonary disease.
- •planning to become pregnant in the next 1.5 years
- •patients with inadequate contraception
- •not consenting to the study
研究组 & 干预措施
Treatment group
Experimental
干预措施: Pegaferon (pegylated interferon alpha 2a) + ribavirin (Drug)
结局指标
主要结局
Sustained viral response
时间窗: 6 months after end of treatment
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
次要结局
- Adverse drug events(18 months from start of treatment)
研究者
研究点 (2)
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