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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00172809
Date of registration: 12/09/2005
Primary sponsor: National Taiwan University Hospital
Public title: Interferon Treatment for Patients With Chronic Hepatitis C and End Stage Renal Disease
Scientific title: A Pilot Study in Comparing the Efficacy and Safety of Peginterferon Alfa-2a and Interferon Alfa-2a in Treating Patients With End Stage Renal Disease and Chronic Hepatitis C
Date of first enrolment: July 2005
Target sample size: 50
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Hepatitis C
End Stage Renal Disease
Drug: Interferon alfa-2a
Drug: Peginterferon alfa-2a
Primary Outcome(s)
Sustained histological response and sustained virological response 6 months after the completion of the intervention [Time Frame: 1 year]
Secondary Outcome(s)
The overall tolerance of the two different regimens and the comparison of the rates of side effects [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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