NCT02726022 - A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels | Crick

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

114

Conditions

Hepatitis C, Chronic

Interventions

Peginterferon alfa-2aDRUG

As per treating physician discretion and according to summary of product characteristics.

RibavirinDRUG

As per treating physician discretion and according to summary of product characteristics.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Aigaleo - Attiki, Greece

Unnamed facility

Athens, Greece

Unnamed facility

Athens, Greece

Unnamed facility

Athens, Greece

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).