Chronic Hepatitis C Clinical Trial
Official title:
Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Who Fail Interferon Alfa or Pegylated Interferon Alfa Monotherapy - a Pilot Study
Verified date | October 2009 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon
(IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in
immunocompetent patients. Two meta-analyses evaluating the efficacy and safety of
conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates
were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%,
respectively. The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis
patients showed conflicting results, with a more favorable outcome of patients treated with
pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with
pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), Currently, IFN-based
therapy to treatment HCV infection should be initiated in dialysis stages, because the use
of IFN in RT patients harbors high risks of acute graft rejection,and have low response
rates under the concomitant use of immunosuppressive agents.
Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the
general patients and achieve a higher SVR rate than IFN monotherapy, is considered
contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe
hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus
low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of
treatment.In addition, a recent study including 6 patients with combination of pegylated IFN
alfa plus low dose ribavirin also showed a SVR rate of 50%.
Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN
monotherapy than patients with normal renal function for HCV therapy. More than half of
these patients are relapsers or non-responders to IFN monotherapy. Retreatment of
HCV-patients with normal renal function by combined pegylated IFN alfa plus ribavirin who
fail to response to IFN monotherapy has achieved a SVR rate of 28%. Based on the long-term
favorable outcome in dialysis patients who eradicate HCV, the aim of the study is to
evaluate the efficacy and safety of retreatment by pegylated IFN alfa-2a plus low dose
ribavirin in dialysis patients who fail to achieve HCV eradication by conventional or
pegylated IFN alfa.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Non-responders or relapsers of dialysis patients to conventional interferon or pegylated interferon monotherapy - 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 - Detectable serum quantitative HCV-RNA (Cobas Taqman HCV Monitor v2.0, Roche Diagnostics) with dynamic range 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Department of Health, Executive Yuan, R.O.C. (Taiwan), National Science Council, Taiwan |
Taiwan,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs) | 1.5 year | Yes | |
Secondary | Number of Participants With Histologic Response(HR) | 1.5 year | No |
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