Hepatitis C
Conditions
Keywords
hepatitis C, Ribavirin, Dosage, Pharmacokinetics
Brief summary
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.
Detailed description
The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily. The pharmacokinetics of ribavirin at different dosage regimes is investigated.
Interventions
DRUGRibavirin
different dosing regimes of Ribavirin
Sponsors
Roche Pharma AG
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * body weight at or above 75 kg
Exclusion criteria
* HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph | within 24 weeks after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| The tolerability of the treatment at different dosage regimes of ribavirin | 24 weeks of treatment |
| The antioxidant capacity in plasma and erythrocytes at different dosing regimes | 24 weeks of treatment |
| The effect of ribavirin on the hemolysis | 24 weeks of treatment |
| The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes | 24 weeks of treatment |
Countries
Netherlands
Outcome results
None listed