Chronic hepatitis C in patients with chronic renal failure MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10066622 Term: Chronic hemodialysis
Conditions
Interventions
Trade Name: Pegasys
Pharmaceutical Form: Injection*
Trade Name: Copegus
Pharmaceutical Form: Coated tablet
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Consecutive hemodialysed patients with end-stage renal disease and documented presence of HCV RNA in serum over a period of ?6 months - Age >18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - HCV/HBV or HCV/HIV co-infection - Hematologic disease - Sepsis - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine HCV RNA clearance at different time points during hemodialysis;Secondary Objective: 1. To assess cellular and humoral immunologic parameters in peripheral blood before and after hemodialysis 2. To correlate HCV RNA levels, HCV RNA clearance, and cellular and humoral immunological parameters 3. To compare different hemodialysis methods (low flux hemodialysis versus high flux hemodiafiltration) on HCV RNA levels, HCV RNA clearance, and cellular and humoral immunological parameters 4. To assess sustained virological response (SVR) to antiviral treatment with peginterferon plus ribavirin 5. To relate SVR to HCV clearance and cellular and humoral immunological parameters ;Primary end point(s): HCV RNA level | — |
Countries
Austria
Outcome results
None listed