A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) 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) ;
- •Positive HCV antibody
- •Serum HCV RNA of ≥ 1 × 104 IU/mL
- •Hepatitis C virus GT1
- •Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
- •The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis
- •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, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
- •Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL
- •Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
- •Others as specified in the detailed protocol
研究组 & 干预措施
Danoprevir,Ritonavir, Peg-IFN,RBV
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.
干预措施: Danoprevir (Drug)
Danoprevir,Ritonavir, Peg-IFN,RBV
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.
干预措施: Ritonavir (Drug)
Danoprevir,Ritonavir, Peg-IFN,RBV
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.
干预措施: peginterferon alfa-2a (Drug)
Danoprevir,Ritonavir, Peg-IFN,RBV
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.
干预措施: Ribavirin (RBV) (Drug)
结局指标
主要结局
Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
时间窗: 24 weeks
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
次要结局
未报告次要终点