A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 主要终点
- Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •Chronic HCV infection (≥ 6 months)
- •Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
- •Hepatitis C virus GT1
- •Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
- •Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
- •Others as specified in the detailed protocol
排除标准
- •Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
- •Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
- •History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
- •Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
- •Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
- •Patients with obvious cardiovascular dysfunction
- •Pregnant or nursing female, nor unwilling to take reliable contraception
- •Others as specified in the detailed protocol
研究组 & 干预措施
Danoprevir, Ritonavir, Peg-IFN,RBV
Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.
干预措施: Danoprevir (Drug)
Danoprevir, Ritonavir, Peg-IFN,RBV
Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.
干预措施: Ritonavir (Drug)
Danoprevir, Ritonavir, Peg-IFN,RBV
Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.
干预措施: peginterferon alfa-2a (Drug)
Danoprevir, Ritonavir, Peg-IFN,RBV
Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: 12 weeks
次要结局
未报告次要终点