JPRN-UMIN000025487已完成未知
Post-marketing, prospective and non-randomized trial regarding to daclatasvir and asunaprevir combination therapy for chronic liver disease with genotype 1 hepatitis C virus - daclatasvir and asunaprevir combination therapy for chronic liver disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 182
研究概览
简要总结
The undetectable rate of HCV RNA 24 weeks after the end or stop of treatment was 90.6%. During the treatment, adverse effects were seen in 123 patients. The most frequent adverse effect was elevation of transaminase. There was no difference in rate of sustained viral response or frequency of adverse effect between non-elderly and elderly patients. Conclusions: Efficacy and safety during DCV and ASV combination therapy for elderly patients were similar to non-elderly patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Previously treatment with daclatasvir and asnaprevir or other NS5A replication complex inhibitor. Decompensated cirrhosis (i.e.Child Pugh grade B or C cirrhosis). Untreated variceal hemorrhage, hepatic encephalopathy or uncontrollable ascites. HBs antigen and or human immunodeficiency virus antibody are positive. Current hepatocellular carcinoma diagnosed by US, CT or MRI(=<1 year from enrollment). Severe or uncontrolled disorder (i.e. myocardial infarction, heart failure, arrhythmia, cerebral infarction). Gastrointestinal disorder that could interfere with the absorption of the study drugs. Significant drug allergy (such as anaphylaxis or hepatotoxicitys). Advanced cancer untreated or during treatment. History of organ implantation.Findings of organ failure or unstableorgan functio. Woman in pregnancy or having a possibility that she may be in pregnancy, in nursing. Woman having a possibility of fertility or male whose partner has a possibility of fertility cannot use birth control between first treatment day and 6 months after treatment. Man whose partner is in pregnancy cannot use condom between first treatment day and 6 months after treatment. Abnormality in following laboratory tests: AST>5 times UNV, Total bilirubin>=5 mg/dL, Albumin>3 g/dL, Platelet=<50000/mm^3. Patient taking an incompatible drug. Patient restricted by legal reason. Unsuitable case judged by doctor.
研究者
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