A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
研究概览
简要总结
This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.
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 participants, >/= 18 years of age
- •Participants undergoing an opioid maintenance therapy
- •Serologic evidence of CHC prior to therapy
- •CHC genotype 2, 3, 1 or 4
- •Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
- •All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment
排除标准
- •Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
- •Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
- •Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
- •Current diagnosis of a major depression or any psychotic disorder
结局指标
主要结局
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
时间窗: 24 weeks after completing treatment, within 3 years, 6 months
SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).
次要结局
- Percentage of Participants With SVR 12(12 weeks after completing treatment, within 3 years, 6 months)
- Percentage of Participants With Virological Relapse(by end of follow-up, within 3 years, 6 months)
- Beck Depression Inventory (BDI) Score by Visit(at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months)
- Percentage of Participants With End of Treatment Response(at end of treatment, within 3 years, 6 months)
- Short Form Health Survey (SF-36) Scores by Visit(at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months)
- Fatigue Severity Scale (FSS) Score by Visit(at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months)
- Beschwerdeliste (BL) Score by Visit(at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months)