A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 主要终点
- Percentage of Participants with Sustained Virologic Response (SVR)
研究概览
简要总结
This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.
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
- •Eligible for and scheduled to receive treatment with commercially available PEG-IFN alfa-2a and ribavirin combination
- •Serologic evidence of chronic hepatitis C (CHC) infection
- •Detectable serum hepatitis C virus - ribonucleic acid (HCV-RNA)
- •Negative urine or blood pregnancy test
- •Fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end
排除标准
- •Women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant
- •Received any investigational drug less than or equal to (</=) 6 weeks prior to enrollment
- •Moderate hepatic failure [Child-Pugh greater than or equal to (>/=) B]
- •Co-infection with human immunodeficiency virus (HIV) or hepatitis B
- •Autoimmune hepatitis
- •Known hypersensitivity to alfa interferons, E. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of PEG-IFN alfa-2a or ribavirin
研究组 & 干预措施
Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin
Participants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion.
干预措施: Pegylated interferon (PEG-INF) alfa-2a (Drug)
Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin
Participants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants with Sustained Virologic Response (SVR)
时间窗: Up to Week 72
次要结局
- Percentage of Participants Who Utilized Resources(Baseline, Week 12, 24, 48 and 72)
- Short Form Health Survey (SF-36) Mental Composite Score(Baseline, Week 12, 24, 48 and 72)
- Short Form Health Survey (SF-36) Physical Composite Score(Baseline, Week 12, 24, 48 and 72)
- Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation(Up to Week 72)