Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 9
- 主要终点
- Percentage of Participants Who Were Non-Responders
研究概览
简要总结
This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.
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
- •Adult patients, >/= 18 years of age
- •Serologically confirmed chronic hepatitis C (all genotypes)
- •Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling
排除标准
- •Coinfection with HIV and/or hepatitis B
- •Contraindications according to the SPC for Pegasys/ribavirin
结局指标
主要结局
Percentage of Participants Who Were Non-Responders
时间窗: Up to 24 weeks after EOT (up to Week 96)
Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.
Percentage of Participants With Sustained Virological Response (SVR)
时间窗: 24 weeks after End of treatment (EOT) (up to Week 96)
SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction \[PCR\] measured greater than or equal to \>=140 days post-treatment).
Percentage of Participants With Relapse
时间窗: Up to 24 weeks after EOT (up to Week 96)
Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.
次要结局
- Correlation of SVR With Rapid Virological Response (RVR)(Up to 24 weeks after EOT (up to Week 96))
- Percentage of Participants With Positive Predictive Value on SVR at Week 4(Week 4)
- Duration of Treatment in Participants With SVR by HCV Genotype(Up to Week 72)
- Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype(Up to Week 72)
- Percentage of Participants With Virological Response(4 weeks after EOT (up to Week 76))
- Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype(Up to Week 72)
- Correlation of SVR With Early Virological Response (EVR)(Up to 24 weeks after EOT (up to Week 96))
- Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response(Week 4 and 12)
- Percentage of Participants With Positive Predictive Value on SVR at Week 12(Week 12)