An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and Ribavirin With Pegasys (Peginterferon Alfa-2a) and Ribavirin for Treatment of Patients With Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 170
- 试验地点
- 19
- 主要终点
- EVR
研究概览
简要总结
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
详细描述
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on PCR data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / Pegasys and ribavirin for another 12 or 36 weeks (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent to participate in the study.
- •Chronic HCV infection (genotypes 1а, 1b, 2, 3, 4) with detectable HCV RNA >6 month before the screening visit or abnormal ALT levels for >6 month before the screening visit.
- •Male and female patients, 18 to 70 years of age, inclusive.
- •Body mass index of 18 - 30 kg/m
- •Preserved protein synthetic liver function (INR < 1.7, albumin > 35 g/l).
- •No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
- •Fertile patients and their partners agree to use barrier contraception throughout the study treatment and 7 months after it.
- •Patient must have documentation of fibroscan within 1 year before the screening visit or agree to have a fibroscan within the screening period.
排除标准
- •Intolerance to IFN alfa, ribavirin or any components of this preparations confirmed by past medical history.
- •Infection by hepatitis B, A, E virus or HIV (co-infection).
- •Any other documented significant liver disease (drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, biliary cirrohosis, etc.).
- •Past history of HCV treatment with IFN alfa or pegylated IFN alfa.
- •Administration of injectable and non-injectable interferons and/or some interferon inducers for any indication (other than HCV) for one month before enrollment into the study.
- •Cholestatic hepatitis (level of conjugated bilirubin, alkaline phosphatase, G-GTP exceeding the upper normal level by more than 5 times).
- •Decompensated liver cirrhosis confirmed by laboratory findings (class B, С according to Child-Pugh) or ultrasound examination.
- •Any documented autoimmune diseases (e.g., Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune haemolytic anemia, severe psoriasis).
- •Hemoglobin not lower than low normal level; neutrophils < 1.5 х109/L; platelets < 90 х109/L; creatinin level exceeding the upper normal level by more than 1.5 times, ALT level exceeding the upper normal level by more than 10 times.
- •Documented hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
- •Severe depression, schizophrenia, other mental disorders, which from the investigator's point of view are a contraindication for anti-viral treatment.
- •Epilepsy and/or disorder of function of the central nervous system.
- •Abnormal thyroid function (TTH level beyond the normal values).
- •Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alfa-fetoprotein (AFP) of ≥ upper normal level.
- •Antinuclear antibody (ANA) titer ≥1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy.
- •Malignant neoplasms.
- •Pregnancy, lactation period.
- •Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus) that represent a contraindication for anti-viral treatment.
- •Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
- •Known drug or alcohol abuse or signs of drug/alcohol abuse in present, which from the investigator's point of view are a contraindication for anti-viral treatment or restrict adherence to the treatment regimen.
- •Simultaneous participation in other clinical studies less than 30 days before enrollment into this study or previous participation in this clinical study.
研究组 & 干预措施
Algeron
Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
干预措施: Algeron (Drug)
Pegasys
Pegasys in a dose of 180 µg subcutaneously, once a week, in combination with Rebetol, orally, at a daily dose of 800 mg for patients with genotype 2 or 3, and for genotypes 1 or 4 at a daily dose of 1000 mg (for body weight <75 kg) or 1200 mg (for body weight ≥75 kg)
干预措施: Pegasys (Drug)
结局指标
主要结局
EVR
时间窗: 12 weeks
Proportion of randomized patients achieving early virologic response (EVR) - negative PCR result for HCV RNA (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment
次要结局
- RVR(4 weeks)
- EOT(After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4)
- Biochemical Response(12, 24, 48 weeks of treatment, and 24 weeks after last dose of study treatment)
- Histological Response(12 weeks of treatment and 24 weeks after last dose of study treatment)
- SVR (24)(24 weeks after last dose of study treatment)