NCT02480686已完成4 期
Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
Humanity and Health Research Centre2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
研究概览
简要总结
This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years, with chronic genotype 1b infection;
- •HCV RNA equal to or greater than 10,000 IU/mL at Screening;
- •Cirrhosis determination;
- •Subjects who are treatment-experienced;
- •Screening laboratory values within defined thresholds;
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male.
排除标准
- •HIV or chronic hepatitis B virus (HBV) infection;
- •Contraindications for PEG or RBV therapy;
- •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);
- •Chronic use of systemic immunosuppressive agents;
- •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+PEG+RBV
Experimental
Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.
干预措施: SOF+PEG+RBV (Drug)
结局指标
主要结局
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
时间窗: Baseline up to Week 24
Adverse events leading to permanent discontinuation of study drug(s)
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (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
- Change in HCV RNA From Baseline to Week 12(Baseline up to Week 24)
- Proportion of participants with on-treatment virologic breakthrough and relapse(Baseline up to Week 24)
研究者
研究点 (2)
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