E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C virus infection. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-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?
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E.2.2 | Secondary objectives of the trial |
-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? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The pharmacokinetics of Ribavirin after different dosing regimes, measured by the area under the concentration-time curve. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |