NCT03181074已完成不适用
Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年10月21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
- 10
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.
排除标准
- •Subjects who received daclatasvir as part of a clinical trial.
- •Subjects who received daclatasvir for any indication other than local approved.
- •Contraindications included in the approved Mexican prescribing information.
结局指标
主要结局
Number of Adverse Events
时间窗: Approximately 24 months
adverse events (AEs) on treatment with DCV in patients with chronic hepatitis C treated by doctors at participating sentinel sites for the CNFV in Mexico
次要结局
- Distribution of Adverse Events by Age(Approximately 24 months)
- Distribution of Adverse Events by Gender(Approximately 24 months)
- Distribution of Adverse Events by Interruption or Switch of Medication(Approximately 24 months)
- Distribution of Adverse Events by Concomitant Medication(Approximately 24 months)
- Distribution of Adverse Events by Race(Approximately 24 months)
研究者
研究点 (1)
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