Evaluation of HCV clearance by hemodialysis

Phase 1

Active, not recruiting

Conditions: Chronic hepatitis C in patients with chronic renal failure
MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
MedDRA version: 9.1Level: LLTClassification code 10066622Term: Chronic hemodialysis

Registration Number: EUCTR2008-006772-30-AT

Lead Sponsor: Medical University of Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

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

- HCV/HBV or HCV/HIV co-infection
- Hematologic disease
- Sepsis
- Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. To correlate HCV RNA levels, HCV RNA clearance, and cellular and humoral immunological parameters<br>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<br>4. To assess sustained virological response (SVR) to antiviral treatment with peginterferon plus ribavirin<br>5. To relate SVR to HCV clearance and cellular and humoral immunological parameters<br>;Primary end point(s): HCV RNA level

Secondary Outcome Measures