Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,974
- 试验地点
- 1
- 主要终点
- The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
研究概览
简要总结
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.
详细描述
Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated
Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study
排除标准
- 未提供
结局指标
主要结局
The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
时间窗: 28 weeks
次要结局
- Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)(48 weeks)