Triple Combination DAAs for Ultra Short Duration Therapy for HCV Genotype 1b in Chinese (SODAPI II Study)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)
研究概览
简要总结
There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA positive >2000 IU/ml or NAT POC positive
- •Genotype 1b
- •CP score ≤6
排除标准
- •Pregnant or nursing female or male with pregnant female partner
- •Hematologic or biochemical parameters at Screening outside the protocol- specified requirements
- •Active or recent history (≤ 1 year) of drug or alcohol abuse
- •Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
研究组 & 干预措施
SOF+DCV+SMV 3-4 wks
Patients without cirrhosis will receive sofosbuvir, daclatasvir and simeprevir for (a) 3 weeks if HCV viral load on day 2 is <500 IU/ml or (b) 4 weeks if HCV viral load on day 2 is >500 IU/ml.
干预措施: SOF+DCV+SMV (Drug)
SOF+DCV+SMV 6-8 wks
Patients with cirrhosis and CP-A will receive sofosbuvir, daclatasvir and simeprevir (a) 6 weeks if HCV VL on day 2 is <500 IU/ml or (b) 8 weeks if HCV VL on day 2 is >500 IU/ml.
干预措施: SOF+DCV+SMV (Drug)
结局指标
主要结局
Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)
时间窗: Post treatment Week 12
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
次要结局
- Frequency and severity of adverse events(Baseline up to Week 24)
- Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment(Baseline up to Week 24)
- Kinetics of circulating HCV RNA during treatment and after treatment discontinuation(Baseline up to Week 24)
- Proportion of participants with on-treatment virologic breakthrough and relapse(Baseline up to Week 24)