A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Hepatitis C Participants<br>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. | Drug: Peginterferon alfa-2a<br>* As per treating physician discretion and according to summary of product characteristics.<br>* Other names: Pegasys;Drug: Ribavirin<br>* As per treating physician discretion and according to summary of product characteristics.<br>* Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | 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). | Baseline, EOT (up to 48 weeks) | 
| Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | 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). | Baseline, 24 weeks after EOT (up to 72 weeks) | 
| Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | 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). | Baseline, EOT (up to 48 weeks) | 
| Change From Baseline in SF-36 PCS at 24 Weeks After EOT | 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). | Baseline, 24 weeks after EOT (up to 72 weeks) | 
| Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | 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). | Baseline, EOT (up to 48 weeks) | 
| Change From Baseline in SF-36 MCS at 24 Weeks After EOT | 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). | Baseline, 24 weeks after EOT (up to 72 weeks) |