Trial | NCT00917358  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    42
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.
Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. The high incidence and prevalence in thse patients are attributed to potential nosocomial exposure to hepatitis C virus during dialysis, resulting in high rates of acute hepatitis C virus infection. It is estimated that about 65-80% of the patients who have acute hepatitis C will evolve to chronic infection, leading to chronic hepatitis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Currently, interferon and pegylated interferon monotherapy remains effective to treat acute hepatitis C in ordinary patients, with the sustained virologic response (SVR) rates ranging from 65-90% after 12-24 weeks of therapy. However, few data regarding the efficacy and safety of interferon-based monotherapy is known till now. Treatment of weekly 135 pegylated interferon alfa-2a has shown superior safety to thrice weekly 3 million unit (MU) standard interferon alfa-2a for dialysis patients with chronic hepatitis C. Under the excellent safety profiles of treating dialysis patients with low dose pegylated interferon alfa-2a, we aimed to evaluate the efficacy of weekly 135 ug pegylated interferon alfa-2a for a total of 24 weeks for dialysis patients with acute hepatitis C, and also evaluate the SVR rate by retrospective chart review for dialysis patients with acute hepatitis C who did not receive interferon-based therapy to evaluate if early intervention for these patients will improve overall disease outcome.
Study Started
Jul 31
2005
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Dec 20
2012
Estimate

Drug Pegylated interferon alfa-2a

Pegylated interferon alfa-2a 135 ug/week for 24 weeks

  • Other names: Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)

Pegylated interferon alfa-2a Experimental

Pegylated interferon alfa-2a 135 ug/week for 24 weeks

Observation No Intervention

Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention

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
No Results Posted