NCT00418054已完成2 期
Phase II, Multi-Center, Randomized, Double-Blind Study of Nitazoxanide Tablets Combined With Peginterferon Compared to Peginterferon Monotherapy 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
- 40
- 试验地点
- 2
- 主要终点
- Virologic response
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.
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.
- •HCV genotype
- •Patients that have not previously received peginterferon.
排除标准
- •Patients unable to take oral medications.
- •Use of ribavirin within 30 days prior to enrollment.
- •Females 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 other than through Romark study number RM01-
- •Patients with other causes of liver disease.
- •Transplant recipients receiving immune suppression therapy.
- •Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay.
- •Patients with decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores >
- •Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of >20 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 any of the excipients comprising the nitazoxanide tablets or peginterferon alfa-2b solution for injection.
结局指标
主要结局
Virologic response
次要结局
- 2 log drop in serum HCV RNA
- Change in ALT
研究者
研究点 (2)
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