A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Sustained virological response (SVR)
研究概览
简要总结
Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Serum Hepatitis C RNA > 10,000IU/mL
- •Hepatitis C virus genotype 1
- •IL28B CC polymorphism
排除标准
- •Previous treatment for chronic Hepatitis C
- •clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- •HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
- •Contraindications to PR-based treatment:
- •Uncontrolled psychiatric illness
- •Active substance dependency
- •Known autoimmune disorder
- •Untreated thyroid disease
- •Uncontrolled seizure disorder
- •Pregnancy, lactation or inability to maintain contraception
- •Chronic kidney disease w/ estimated GFR< 60
- •ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl
- •Clinical or biochemical evidence of decompensated liver disease including:
- •History of encephalopathy
- •Variceal bleeding
- •Bilirubin > 3g/dl or INR > 1.5
- •Life threatening disorder with expected median survival less than 5 years
- •Inability to comply with drug regimens or testing schedule required for study
研究组 & 干预措施
24-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks
干预措施: Peginterferon alfa2a (Drug)
24-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks
干预措施: Ribavirin (Drug)
48-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks
干预措施: Peginterferon alfa2a (Drug)
48-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained virological response (SVR)
时间窗: 24 weeks after the end of treatment
Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment
次要结局
- Sick leave in patients treated for 24 or 48 weeks treatment(48 weeks)
- Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment(baseline, 24 weeks after the end of treatment)
研究者
Cai Qingxian
Third Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University