NCT00763568已完成2 期
Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sustained virologic response
研究概览
简要总结
The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C
排除标准
- •Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
- •Unable to take oral medication.
- •Females who are either pregnant, breast-feeding or not using birth control.
- •Males whose female partners are pregnant or plan to become pregnant.
- •Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
- •Patients with HIV, HAV, HBV or HDV.
- •Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
- •Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
- •History of hypersensitivity or intolerance to nitazoxanide or peginterferon.
研究组 & 干预措施
Nitazoxanide
Experimental
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
干预措施: Nitazoxanide (Drug)
Nitazoxanide
Experimental
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
干预措施: Peginterferon alfa-2a (Biological)
结局指标
主要结局
Sustained virologic response
时间窗: 24 weeks after the end of treatment
次要结局
- End of treatment virologic response(At the end of treatment)
- Early virologic response(After 12 weeks of combination therapy)
- Rapid virologic response(After 4 weeks of combination therapy)
- ALT normalization(24 weeks after the end of treatment)
研究者
研究点 (1)
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