NCT02639585Unknown4 期
Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Sustained Virologic Responase
研究概览
简要总结
We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.
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
- •Males and females, ≥ 18 years of age
- •HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
- •HCV RNA ≥ 10,000 IU/mL
- •Subjects with compensated cirrhosis are permitted
- •Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
- •Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and all females with childbearing potential must use reliable contraception method during the study and for 3 months after treatment completion.
排除标准
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study
- •Other than genotype 1 infection
- •Prior treatment of HCV with HCV direct acting antiviral agents (DAA)
- •Patient who has any history of major organ transplantation with an existing functional graft or Patient who has plan to receive organ transplant
- •Diagnosed or suspected hepatocellular carcinoma or other malignancies
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
- •Evidence of a medical condition contributing to chronic liver disease other than HCV
- •Uncontrolled diabetes or hypertension
- •Women with ongoing pregnancy or who are breast feeding
- •Evidence of alcohol and/or drug abuse
- •Patient who has NS5A resistance associated variant
研究组 & 干预措施
Treatment arm
Experimental
Daclinza and Sunvepra
干预措施: Daclinza and Sunvepra (Drug)
结局指标
主要结局
Sustained Virologic Responase
时间窗: week 12 (after treatment)
次要结局
未报告次要终点
研究者
Won Lim
Assistant Professor, Department of Internal Medicine
Pusan National University Hospital
研究点 (2)
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