A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
研究概览
简要总结
Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.
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
- •Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
- •HCV ribonucleic acid (RNA) positive
- •CHC with normal transaminases
- •Compensated liver disease
- •Non-pregnant and willing to use two contraceptive methods (if fertile)
- •At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin
排除标准
- •Pregnant or lactating women
- •Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
- •History of seizures or depression
- •History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
- •Uncontrolled thyroid disease
- •Severe retinopathy
- •Leukopenia or thrombocytopenia
- •Bleeding esophageal varices or other evidence of hepatic decompensation
研究组 & 干预措施
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.
干预措施: Peginterferon alfa-2a (Drug)
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
时间窗: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
时间窗: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
时间窗: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
时间窗: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
时间窗: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
时间窗: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
次要结局
未报告次要终点