Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 主要终点
- Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin
研究概览
简要总结
Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).
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
- •Adult patients with hepatitis C
排除标准
- •According to the products' European labeling
研究组 & 干预措施
PegIFN-2b/ribavirin with substitution therapy
Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
干预措施: Pegylated interferon alfa-2b (PegIFN-2b) (Biological)
PegIFN-2b/ribavirin with substitution therapy
Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
干预措施: Ribavirin (Drug)
PegIFN-2b/ribavirin without substitution therapy
Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
干预措施: Pegylated interferon alfa-2b (PegIFN-2b) (Biological)
PegIFN-2b/ribavirin without substitution therapy
Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin
时间窗: 24 to 48 weeks
For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
次要结局
- Number of Participants Who Achieved Sustained Virologic Response (SVR)(24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype))
- Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy(Day 1)