NCT00418639已完成2 期
Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Virologic response
研究概览
简要总结
This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Age ≥ 18 years.
- •Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
- •Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
排除标准
- •Patients unable to take oral medications.
- •Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
- •Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
- •Any investigational drug therapy within 30 days prior to enrollment.
- •Patients with other causes of liver disease.
- •Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
- •Patients with history of alcoholism or with an alcohol consumption of >40 grams per day.
- •Patients who are clinically unstable.
- •Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
- •History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.
结局指标
主要结局
Virologic response
次要结局
- Sustained virologic response
- Quantitative serum HCV RNA
- Changes in ALT
研究者
研究点 (3)
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