STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
研究设计
- 研究类型
- Interventional
- 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
- •Adult patients of East Asian or Southeast Asian origin, >/= 18 years of age
- •Presence of chronic genotype 1 hepatitis C infection
- •Treatment-naïve
排除标准
- •History or presence of decompensated liver disease
- •Presence or history of non-hepatitis C chronic liver disease
- •Positive for hepatitis B or HIV infection
研究组 & 干预措施
with cirrhosis
干预措施: danoprevir + ritonavir (Drug)
with cirrhosis
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
with cirrhosis
干预措施: ribavirin [Copegus] (Drug)
without cirrhosis
干预措施: danoprevir + ritonavir (Drug)
without cirrhosis
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
without cirrhosis
干预措施: ribavirin [Copegus] (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 1.5 years
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System
时间窗: from baseline to Week 36/48
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study
时间窗: approximately 1.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
时间窗: up to 14 days
次要结局
- SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12(approximately 1.5 years)
- Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4(approximately 1.5 years)
- Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12(approximately 1.5 years)
- Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration(approximately 1.5 years)
- Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration(approximately 1.5 years)
- Incidence of viral resistance to danoprevir(approximately 1.5 years)