Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Incidence of SVR
研究概览
简要总结
This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor. The planned observation time is 48 weeks and 24 weeks of follow-up.
Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Willing to consent to data being collected
- •Considered by the investigator as an appropriate patient for treatment with INFERGEN in retreatment.
排除标准
- 未提供
结局指标
主要结局
Incidence of SVR
时间窗: 24 weeks post end of therapy
•Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV, in retreatment.
次要结局
- Safety profile(Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24)