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

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: Peginterferon alfa-2a

Study type: Observational

Funder types: Industry

Identifiers

NCT02726022

ML20151

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

114 participants in 1 patient group

Chronic Hepatitis C Participants

Description:

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.

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a