Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 933
- 试验地点
- 159
- 主要终点
- Sustained virologic response (SVR)
研究概览
简要总结
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic hepatitis C.
- •Liver biopsy performed within 2 years of Day 0 or during screening.
- •Infected with hepatitis C virus genotype 2/
- •Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
- •Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
- •Have compensated liver disease.
排除标准
- •Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
- •History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
- •Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
- •Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
- •A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
- •Active seizure disorder within the last 2 years.
- •Organ transplant other than cornea and hair transplant.
- •Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
- •Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
- •Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
- •Received any experimental agent within 28 days prior to Day 0.
研究组 & 干预措施
1
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
干预措施: albumin interferon alfa-2b (Drug)
1
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
干预措施: Ribavirin (Drug)
2
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
干预措施: albumin interferon alfa-2b (Drug)
2
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
干预措施: Ribavirin (Drug)
3
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
干预措施: peginterferon alfa-2a (Drug)
3
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained virologic response (SVR)
时间窗: Week 48
次要结局
- Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)(Througout the entire treatment period)
- Rapid virologic response(Week 4)
- Early virologic response(Week 12)
- Undetectable HCV RNA(Week 24)
- Normalization of ALT (a liver enzyme)(Week 48)
- Quality of life evaluation(Week 48)