Ribavirin: its dosing regime. - Ribados

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

The inclusion criteria for the accepted standard treatment, which are:
-Anti-HCV positivity > 6 months
-Positive HCV-RNA genotype 1 or 4
-Liver biopsy within one year before the start of therapy
-Intention to be treated and participate treatment

Additional inclusion criteria for this study:
-Obtained written informed consent
- Age above 18 years
- Body weight > 75 kg
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

The exclusion criteria for the accepted standard treatment, which are:
-Pregnancy or intention to get pregnant within the treatment period and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
-Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
-Life expectancy <1 year
-Child Pugh B or C
-Creatinin > 150 µmol/l or > 1.70 mg/dl
Hemoglobin < 6.5 mmol/l or 10.5 g/dl,
White Blood Cells < 2.5 x 109/l,
neutrophil < 1.5 x 109/l,
platelet count < 70 x 109/l
-HIV positivity
-Chemotherapy, systemic antiviral treatment during the six months prior to study entry
-Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
-Active uncontrolled psychiatric disorders and suicidal leanings
-Patients with a history of uncontrolled seizure or other significant CNS dysfunction
-Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -Is the area under the concentration-time curve after 2 x 600 mg equal to the area under the concentration-time curve after 1 x 1200mg at steady state of Ribavirin therapy?<br><br><br>;Primary end point(s): The pharmacokinetics of Ribavirin after different dosing regimes, measured by the area under the concentration-time curve.;Secondary Objective: -What is the pharmacokinetics of Ribavirin in erythrocytes after 2 x 600 and after 1 x 1200 mg?<br>-What is the change of the antioxidant capacity in plasma and erythrocytes after 2 x 600 mg and 1 x 1200 mg?<br>-Are there any indications for decreased tolerability after 1 x 1200 mg in comparison to 2 x 600 mg?<br>-Are the side effects more pronounced in single dosage in comparison to two separate dosages?<br>-What is the effect of Ribavirin on the hemolysis?

Secondary Outcome Measures