A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 主要终点
- Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression
研究概览
简要总结
This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/=18 and <70 years of age at initiation of treatment
- •Body weight between 50 kg and 125 kg at baseline
- •Chronic hepatitis C, genotype 1
- •Chronic liver disease consistent with HCV infection
- •Compensated liver disease (Child-Pugh Grade A)
排除标准
- •Pregnant or lactating women, and male partners of pregnant women
- •Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
- •Previous treatment with interferon or ribavirin
- •Positive for hepatitis A, hepatitis B or HIV infection
- •History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
- •Decompensated liver disease and/or liver disease Child-Pugh classification >6
- •Hepatocellular carcinoma
- •History or evidence of esophageal bleeding
- •Hemoglobinopathy, or any other cause for possible hemolysis
- •Hb <11 g/dL in women, <12 g/L in males
研究组 & 干预措施
Peginterferon Alfa-2a Plus Ribavirin
干预措施: peginterferon alfa-2a (Drug)
Peginterferon Alfa-2a Plus Ribavirin
干预措施: ribavirin [Copegus] (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression
时间窗: At Week 72
Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.
Percentage of Participants With Incidence of Anemia
时间窗: Up to Week 72
Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb \< 11 gram per decilitre (g/dL) for women and Hb \< 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.
次要结局
- Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12(From Baseline (Week 0) to Week 12)
- Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment(Up to Week 72)
- Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression(Weeks 4, 12, 24, 48, 60 and 72)