Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the world's population. The current standard of therapy is pegylated interferon and ribavirin, reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week course of combination therapy has achieved a higher successful rate that a 24 weeks course of therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has comparable or even better response to a 48 week course of therapy in Western countries. Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: National Science Council, Taiwan
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Treatment naïve

• Age 18 and older than 18 years old

• Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months

• Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with dynamic range 600~<500,000 IU/ml

• HCV genotype 1 (Inno-LiPA HCV II, Innogenetics, Ghent, Belgium)

• Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment

• A liver biopsy consistent with the diagnosis of chronic hepatitis C

Exclusion Criteria:

• Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)

• Neutropenia (neutrophil count <1,500 per cubic milliliter)

• Thrombocytopenia (platelet <90,000 per cubic milliliter)

• Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Chronic alcohol abuse (daily consumption > 20 gram per day)

• Decompensated liver disease (Child-Pugh class B or C)

• Serum creatinine level more than 1.5 times the upper limit of normal

• Autoimmune liver disease

• Neoplastic disease

• An organ transplant

• Immunosuppressive therapy

• Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus

• Evidence of drug abuse

• Unwilling to have contraception