A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
研究概览
简要总结
In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.
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
- •Male and female patients >/= 18 years
- •Positive test for HCV
- •Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels
排除标准
- •Concomitant infection with HIV or hepatitis B
- •Participation in a clinical trial within 30 days prior to study start
- •Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels
研究组 & 干预措施
Peginterferon alfa-2a + Ribavirin
干预措施: Peginterferon alfa-2a (Drug)
Peginterferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
时间窗: 6 months after the last study drug administration (up to 123.6 weeks)
SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).
次要结局
- Percentage of Participants With Undetectable HCV RNA(Weeks 4, 12 and at end of treatment (up to 99.6 weeks))
- HCV RNA Values(Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks))
- Leukocyte Values(Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks))
- Hemoglobin Values(Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks))
- Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin(Up to 99.6 Weeks)
- Thrombocyte Values(Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks))