A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection Drug Use
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 17
- 主要终点
- Treatment Efficacy
研究概览
简要总结
This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.
详细描述
The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age
- •chronic HCV infection
- •HCV genotype 2/3 infection
- •active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy
- •compensated liver disease
- •negative pregnancy test (within 24 hours of first dose of study medication)
- •effective contraception for the duration of the study
- •written informed consent
排除标准
- •previous interferon or ribavirin therapy
- •investigation drug use in the 6 weeks prior to first dose of study medication
- •infection with HCV genotypes other than 2/3
- •HIV infection
- •HBV infection
- •ongoing severe psychiatric disease
- •frequent drug use that is judged by the treating physician to compromise treatment safety
- •standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin
研究组 & 干预措施
Standard Treatment Duration (24 weeks)
Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).
干预措施: Pegylated interferon alfa 2b (Drug)
Standard Treatment Duration (24 weeks)
Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).
干预措施: Ribavirin (Drug)
Shortened Treatment Duration (12 Weeks)
Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).
干预措施: Pegylated interferon alfa 2b (Drug)
Shortened Treatment Duration (12 Weeks)
Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).
干预措施: Ribavirin (Drug)
结局指标
主要结局
Treatment Efficacy
时间窗: 36 weeks
The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
次要结局
- Treatment Adherence(48 weeks)
- Treatment Response (ETR & SVR24)(48 weeks)
- Behavioral and Quality of Life(48 weeks)