Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,128
- 主要终点
- Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
研究概览
简要总结
The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.
详细描述
Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.
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
- •Willingness to sign an Informed Consent
- •Male and female patients >=18 years of age with Chronic Hepatitis C
- •Not previously treated with Peg-Interferons
- •Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)
排除标准
- •Previous treatment with peginterferon
- •Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start
研究组 & 干预措施
Participants with Chronic Hepatitis C (CHC)
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.
干预措施: Peginterferon alfa-2b (Biological)
Participants with Chronic Hepatitis C (CHC)
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.
干预措施: Ribavirin (Drug)
Participants with Chronic Hepatitis C (CHC)
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.
干预措施: Peginterferon alfa-2a (Biological)
结局指标
主要结局
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
时间窗: Measured at baseline
Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
次要结局
- Number of Participants Discontinued From Treatment by Reason for Discontinuation(24 weeks after the end of treatment (total of 48 to 72 weeks))
- Number of Participants With Treatment Failure by Reason for Failure(24 to 48 weeks)