A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
研究概览
简要总结
This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
- •HCV infection
排除标准
- •None specified
研究组 & 干预措施
Participants With Hepatitis C
All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
干预措施: Peginterferon alfa-2a (Drug)
Participants With Hepatitis C
All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
时间窗: Up to 6 years
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
Percentage of Participants With End of Treatment Response
时间窗: 12 months
Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
Percentage of Participants With Sustained Virologic Response 24 (SVR24)
时间窗: 18 months
Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.
次要结局
未报告次要终点