NCT02580474已完成4 期
The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Myeong Jun Song1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年2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
- 21
- 试验地点
- 1
- 主要终点
- the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment
研究概览
简要总结
Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA Positive and Genotype 1b
- •No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months
- •A patient who is on dialysis, or if not MDRD eGFR<30ml/min
- •HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
- •No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H
排除标准
- •A patient who having received Daclatasvir or Asunaprevir
- •Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- •Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV
- •Diagnosed or suspected hepatocellular carcinoma or other malignancies
- •Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
- •Received solid organ or bone marrow transplant
- •Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
- •Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator
- •Known hypersensitivity to study drugs, metabolites, or formulation excipients
- •Who has taken investigational drugs within 2 months.
研究组 & 干预措施
Daclatasvir plus Asunaprevir
Experimental
干预措施: Daclatasvir plus Asunaprevir (Drug)
结局指标
主要结局
the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment
时间窗: 36 Week
次要结局
- Percentage of subjects with ALT normalization at each visit from the baseline(4, 12, 24, 36 week)
- To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment(36 Week)
- Change in HCV RNA at each visit from the baseline(4, 12, 24, 36 week)
- Percentage of subjects who experience viral breakthrough at each visit from the baseline(4, 12, 24, 36 week)
- Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from(4, 12, 24, 36 week)
研究者
Myeong Jun Song
Assistant Professor
The Catholic University of Korea
研究点 (1)
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