Ribavirin: its dosing regime

Phase 4

Completed

Conditions: 10047438
Hepatitis C virus infection

Registration Number: NL-OMON31511

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

According to standard treatment of HCV with ribavirin. Additional for this study:
-Obtained written informed consent
-Age above 18 years
-Body weight >=70 kg: At a lower body weight, a dose of ribavirin is used (400/600mg a day) that cannot be used in this study.;Main inclusion criteria for standard treatment are:
Anti-HCV positivity >6 months
Positive HCV-RNA genotype 1 or 4
Liver biopsy within one year before start of treatment
intention to be treated and participate treatment

Exclusion Criteria

Main exclusioncriteria for the standard treatment are:
Pregnancy or intention to get pregnant within the treatment period + 6 months
no adequate contraception (for men and women)
HIV positivity
Active uncontrolled psychiatric disorders and suicidal leanings
patients with a history of uncontrolled seizure or other significant CNS dysfunction
Chemotherapy, systemic antiviral treatment during 6 months prior to study entry
Other serious disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The pharmacokinetics of ribavirin at different dosage regimes, measured by the<br /><br>area under the curve of the concentration-time graph.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-The tolerability of the treatment at different dosage regimes of ribavirin.<br /><br>-Is the antioxidant capacity in plasma and erythrocytes different for the<br /><br>dosing regimes?<br /><br>-What is the effect of ribavirin on the hemolysis?<br /><br>-What is the antioxidant acitivity of ribavirin?<br /><br>-What is the pharmacokinetics of ribavirin in the different dosing regimes in<br /><br>erythrocytes?</p><br>