Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 主要终点
- Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
研究概览
简要总结
The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be completed prior to the enrollment in the current study. The study will also aim to identify factors that are predictive of relapse. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.
详细描述
Non-probability sampling: The study population consists of adult patients over the age of 18 affected by CHC who were previously treated for the first time with Peg-IFN alfa-2b plus ribavirin and achieved end-of-treatment response. Five hundred ninety patients must be recruited in order to evaluate the objectives of the study. The patients must meet all inclusion criteria and not meet any of the exclusion criteria in order to be included in the study.
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
- •The patient must demonstrate his/her continued willingness to participate in the study.
- •The patient must be at least 18 years of age, of either gender.
- •Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b + 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
- •Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4 weeks before study entry.
- •Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
- •Patients treated for a period shorter than the enrollment period.
- •Patients co-infected with human immunodeficiency virus (HIV).
- •Patients co-infected with hepatitis B virus (HBV).
- •Patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).
研究组 & 干预措施
Peg-IFN alfa-2b + ribavirin
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
干预措施: Peg-IFN alfa-2b (Biological)
Peg-IFN alfa-2b + ribavirin
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
时间窗: 24 weeks post end of treatment (EOT)
HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.
次要结局
- Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment(24 weeks post EOT)
- Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response(Baseline and 24 weeks post EOT)
- Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment(72 weeks post EOT)