An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 697
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
研究概览
简要总结
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).
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
- •Participants with serologically confirmed chronic hepatitis C
- •Participants using and accepting a double method of contraception
排除标准
- •Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
- •Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
- •Participants previously treated with pegylated interferon and/or ribavirin
- •Hepatitis B and Human Immunodeficiency Virus co-infections
研究组 & 干预措施
Pegasys + Copegus
Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
干预措施: Peginterferon alfa-2a (Biological)
Pegasys + Copegus
Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
时间窗: 24 weeks after EOT (maximum up to 96 Weeks)
Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment \[EOT\] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.
次要结局
- Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin(Up to EOT (maximum up to 72 weeks))
- Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism(Up to EOT (maximum up to 72 weeks))
- Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin(Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With Virologic Response(Week 4, 12, 24 and at EOT (maximum up to 72 weeks))
- Percentage of Participants With Viral Relapse or Breakthrough(Up to 24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin(Up to EOT (maximum up to 72 weeks))
- Percentage of Participants With SVR According to Starting Dose of Ribavirin(24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin(24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin(Up to EOT (maximum up to 72 weeks))
- Percentage of Participants With SVR According to Dose Reduction of Ribavirin(24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With SVR According to IL-28B Polymorphism(24 weeks after EOT (maximum up to 96 Weeks))
- Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin(Up to 24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin(Up to 24 weeks after EOT (maximum up to 96 weeks))
- Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin(Up to 24 weeks after EOT (maximum up to 96 weeks))