Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional studies for dialysis patients. The aim of the study is the evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute hepatitis C who did not receive intervention as the reference.

• 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

Criteria

Inclusion Criteria:

• Age 18-65 years old

• Creatinine clearance (Ccr) < 10 ml/min/1.73 m2

• Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive < 6 months with defined seroconversion

• Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml

Exclusion Criteria:

• Severe anemia (hemoglobin < 10 g/dL) or hemoglobinopathy

• Neutropenia (neutrophil count, <1,500/mm3)

• Thrombocytopenia (platelet <90,000/ mm3)

• Co-infection with HBV or HIV

• Chronic alcohol abuse (daily consumption > 20 g/day)

• Autoimmune liver disease

• Decompensated liver disease (Child classification B or C)

• 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

• Unwilling to sign inform consent