Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 主要终点
- Participants With Treatment Success
研究概览
简要总结
The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.
详细描述
Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into:
- •Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates.
- •Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).
排除标准
- •Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing.
- •Co-infected HCV participants (eg, human immunodeficiency virus [HIV] or hepatitis B virus [HBV]).
- •Participants who received their first HCV treatment in relation to a clinical trial.
研究组 & 干预措施
Participants with genotype 1 Hepatitis C Virus infection.
Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
干预措施: Peginterferon alfa-2b (SCH 54031) (Biological)
Participants with genotype 1 Hepatitis C Virus infection.
Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
干预措施: Ribavirin (SCH 18908) (Drug)
结局指标
主要结局
Participants With Treatment Success
时间窗: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.
Identify subgroups of genotype 1 participants to better understand factors affecting response rates \& treatment outcomes \& to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, \& drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).
次要结局
未报告次要终点