Ribavirin, Its Dosing Regime
- Registration Number
- NCT00484328
- Lead Sponsor
- Maastricht University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Ribavirin - 2 Ribavirin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Maastricht
🇳🇱Maastricht, Netherlands