NCT02452814已完成不适用
Long-term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Number of Participants with adverse changes in liver ultrasound results
研究概览
简要总结
Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in Study SPC3649-205 (this would include those who completed study SPC3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).
排除标准
- •Those unwilling to provide informed consent for participation in this study.
- •Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649-205.
结局指标
主要结局
Number of Participants with adverse changes in liver ultrasound results
时间窗: Up to 48 months
次要结局
未报告次要终点
研究者
研究点 (3)
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