Chronic Hepatitis C virus infection. MedDRA version: 8.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV)
Conditions
Interventions
Trade Name: Copegus 200 mg
Product Name: Ribavirin
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791045
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Nutrim
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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? ;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? -What is the change of the antioxidant capacity in plasma and erythrocytes after 2 x 600 mg and 1 x 1200 mg? -Are there any indications for decreased tolerability after 1 x 1200 mg in comparison to 2 x 600 mg? -Are the side effects more pronounced in single dosage in comparison to two separate dosages? -What is the effect of Ribavirin on the hemolysis? | — |
Countries
Netherlands
Outcome results
None listed