Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 主要终点
- Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)
研究概览
简要总结
This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.
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
- •Participants with chronic hepatitis C virus (HCV)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C.
- •Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.
排除标准
- •Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
- •Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
- •Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
- •Participants treated for a period shorter than the enrollment period.
- •Co-infection with Human Immumodeficiency Virus (HIV).
- •Co-infected with Hepatitis B Virus (HBV).
结局指标
主要结局
Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)
时间窗: From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment
Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid
次要结局
- Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)(From 24 weeks post-treatment to 72 weeks post-treatment)