Status:
COMPLETED
Interferon Treatment for Patients With Chronic Hepatitis C and End Stage Renal Disease
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Chronic Hepatitis C
End Stage Renal Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The treatment response with conventional interferon alpha alone in patients with end stage renal disease and chronic hepatitis C is about 33-39%. However, the drop-out rate is 17-29.6%. Pegylated inte...
Detailed Description
Chronic hepatitis C virus (HCV) infection is common among patients with end stage renal disease (ESRD), with the reported prevalence ranging from 8 to 20% in dialysis patients in developed world. In T...
Eligibility Criteria
Inclusion
- Age between 18 to 65 years old
- Creatinine clearance (Ccr) \< 10 ml/min/1.73 m2
- Receiving regular hemodialysis
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive \> 6 months
- Detectable serum HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with dynamic range 600\~\<500,000 IU/ml
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00172809
Start Date
July 1 2005
End Date
January 1 2007
Last Update
March 6 2008
Active Locations (1)
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1
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan