NCT00484328CompletedPhase 4
Ribavirin, Its Dosing Regime
Maastricht University Medical Center1 site in 1 country15 target enrollmentStarted: July 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Experimental
Intervention: Ribavirin (Drug)
2
Experimental
Intervention: Ribavirin (Drug)
Outcomes
Primary Outcomes
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
Time Frame: within 24 weeks after enrollment
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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