Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 10
- 主要终点
- Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
研究概览
简要总结
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 genotype 1.
排除标准
- •Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.
- •Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
- •Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
- •Other causes of liver disease including autoimmune hepatitis.
- •Transplant recipients receiving immune suppression therapy.
- •Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
- •Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score >6 or Model for End-stage Liver Disease (MELD) score >
- •Alcohol consumption of >40 grams per day or an alcohol use pattern that will interfere with the study.
- •Absolute neutrophil count <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
- •Hypothyroidism or hyperthyroidism not effectively treated with medication.
- •Hemoglobin A1C (HgbA1c) >7.5 or history of diabetes mellitus.
- •Body Mass Index (BMI) >
- •History or other clinical evidence of significant or unstable cardiac disease.
- •History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
- •Serious or severe bacterial infection(s).
- •Ulcerative or hemorrhagic/ischemic colitis.
- •Pancreatitis.
- •History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
- •History of uncontrolled severe seizure disorder.
- •Requires concomitant theophylline or methadone.
- •History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
- •History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
- •Hemoglobinopathies.
- •History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.
研究组 & 干预措施
1
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
干预措施: Nitazoxanide (Drug)
1
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
干预措施: Peginterferon alfa-2a (Biological)
1
One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
干预措施: Ribavirin (Drug)
2
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
干预措施: Placebo (Drug)
2
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
干预措施: Peginterferon alfa-2a (Biological)
2
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
时间窗: 24 weeks after end of treatment
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
次要结局
- Changes in ALT(From baseline to end of follow up)
- End of Treatment Response (HCV RNA Below Lower Limit of Detection)(At end of treatment)
- Early Virologic Response (HCV RNA Below Lower Limit of Detection)(After 12 weeks combination treatment)
- Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)(After 4 weeks combination treatment)