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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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