Randomized Study for the Assessment of Nitazoxanide in the Treatment of Chronic Hepatitis C Genotype 4
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response
研究概览
简要总结
Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype 4), worldwide it also poses a significant health burden. To date standard of care treatment (pegylated interferon and ribavirin) give modest results with a sustained virological response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an aim to improve current results. Recent reports have suggested an increased SVR with the addition of Nitazoxanide to standard of care. The results are preliminary and need to be confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to standard of care compared to standard of care alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (male or female), 18 to 65 years of age, with chronic HCV infection
- •BMI < 35
- •Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
- •Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR (international normalized ratio) no more than 1.5, serum albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
- •Acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl
- •Patients must be serum hepatitis B surface antigen (HBsAg) negative
- •Negative Antinuclear Antibodies (ANA) or titer of < 1:160
- •Serum positive for anti-HCV antibodies and HCV-RNA
- •Abdominal Ultrasound obtained within 3 months prior to entry in the study
- •Electrocardiogram for men aged > 40 years and for women aged > 50 years
- •Normal fundus examination
- •Ensure strict measures to avoid conception for both male and female participants by using a proper contraception measure all throughout the course of treatment and six months later
- •Female patients must not breast feed during therapy
排除标准
- •Patients who previously received interferon
- •HgbA1c > 7.5 (glycoslylated haemoglobin)or history of diabetes mellitus
- •BMI > 34
- •Women who are pregnant or breast-feeding
- •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-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab
- •Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score > 6 (Child-Turcot-Pugh) or MELD score > 8
- •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 ULN (upper limit of normal)
- •Hypothyroidism or hyperthyroidism not effectively treated with medication
- •Alcohol consumption of > 40 grams per day or an alcohol use pattern that will interfere with the study
- •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)
- •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
- •History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids
- •Patients with clinically significant retinal abnormalities
- •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
Standard of care
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: Pegylated interferon alfa-2a (Drug)
Standard of care
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: Ribavirin (Drug)
Triple therapy
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: Pegylated interferon alfa-2a (Drug)
Triple therapy
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: Nitazoxanide (Drug)
Triple therapy
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Virologic Response
时间窗: 180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).
sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)
次要结局
- Early Virological Response(90 ± 7 days from the start of pegylated interferon and ribavirin)
- Rapid Virological Response(28 - 33 days after start of Pegylated interferon and ribavirin)
- End-of-treatment Response(48 weeks +- 7 days after starting pegylated interferon and ribavirin)
- Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)(throughout the period of treatment and up to 90 days after end of triple therapy)