NCT03071133已完成不适用
Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2018年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Incidence of Alanine Aminotransferase (ALT) elevation
研究概览
简要总结
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration
排除标准
- •Patients who use the DCV Trio off label
结局指标
主要结局
Incidence of Alanine Aminotransferase (ALT) elevation
时间窗: Up to 36 weeks
measured by immunoassay
Incidence of Aspartate Aminotransferase (AST) elevation
时间窗: Up to 36 weeks
measured by immunoassay
Incidence of Total Bilirubin (tBili) elevation
时间窗: Up to 36 weeks
measured by immunoassay
次要结局
- Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan(Up to 36 weeks)
- Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)(Up to 24 weeks)
- Percentage of patients to experience virologic breakthrough(Up to 36 weeks)
- Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)(Up to 36 weeks)
研究者
研究点 (1)
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