A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
- Registration Number
- NCT02726022
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Hepatitis C Participants Ribavirin 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. Chronic Hepatitis C Participants Peginterferon alfa-2a 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT 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 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 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) 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 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 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).
- Secondary Outcome Measures
Name Time Method