A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 421
- 主要终点
- Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)
研究概览
简要总结
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.
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
- •Adults patients, >/=18 years of age
- •Chronic Hepatitis C, Genotype 1 and 4
- •HCV RNA >/=50,000 IU/mL
- •treatment-naive
排除标准
- •Patients with cirrhosis or incomplete/transition to cirrhosis
- •Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease
研究组 & 干预措施
Group A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Copegus (Drug)
Group A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Danoprevir (Drug)
Group A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Pegasys (Drug)
Group A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Ritonavir (Drug)
Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Copegus (Drug)
Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Danoprevir (Drug)
Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Pegasys (Drug)
Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Ritonavir (Drug)
Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Copegus (Drug)
Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Danoprevir (Drug)
Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Pegasys (Drug)
Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
干预措施: Ritonavir (Drug)
Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
干预措施: Copegus (Drug)
Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
干预措施: Danoprevir (Drug)
Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
干预措施: Pegasys (Drug)
Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
干预措施: Ritonavir (Drug)
Group E
Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
干预措施: Copegus (Drug)
Group E
Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
干预措施: Pegasys (Drug)
结局指标
主要结局
Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)
时间窗: 24 weeks after end of treatment
次要结局
- Evaluation of relapse rate(up to 24 weeks after end of treatment)
- Safety: Incidence of adverse events(from baseline up to 72 weeks)
- Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)(from baseline up to 72 weeks)
- Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)(From baseline up to 72 weeks)
- Evaluation of virological breakthrough (viral load rebound) rate(up to 72 weeks)
- Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)(up to 72 weeks)