Is the area under the curve (AUC) of the dose ribavirin once daily equal to the AUC of a half dose twice daily?
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The pharmacokinetics of ribavirin at different dosage regimes, measured by the
area under the curve of the concentration-time graph.
Secondary outcome
-The tolerability of the treatment at different dosage regimes of ribavirin.
-Is the antioxidant capacity in plasma and erythrocytes different for the
dosing regimes?
-What is the effect of ribavirin on the hemolysis?
-What is the antioxidant acitivity of ribavirin?
-What is the pharmacokinetics of ribavirin in the different dosing regimes in
erythrocytes?
Background summary
The standard treatment of patients with chronic hepatitis C virus 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.
Study objective
Is the area under the curve (AUC) of the dose ribavirin once daily equal to the
AUC of a half dose twice daily?
Study design
Randomized, cross-over, parallel group.
Intervention
One group starts with a half dose ribavirin twice daily and after 12 weeks the
total dose once daily.
The second group starts with the total dose ribavirin once daily and after 12
weeks the half dose twice daily.
Study burden and risks
In addition to the standard treatment, bloodsamples are taken at two different
days. The risk is minimal.
The dosing regime of ribavirin is once daily instead of twice daily (the half
dose). The risk is minimal.
Universiteitssingel 50
6229 ER Maastricht
NL
Universiteitssingel 50
6229 ER Maastricht
NL
Listed location countries
Age
Inclusion criteria
According to standard treatment of HCV with ribavirin. Additional for this study:
-Obtained written informed consent
-Age above 18 years
-Body weight >=70 kg: At a lower body weight, a dose of ribavirin is used (400/600mg a day) that cannot be used in this study.;Main inclusion criteria for standard treatment are:
Anti-HCV positivity >6 months
Positive HCV-RNA genotype 1 or 4
Liver biopsy within one year before start of treatment
intention to be treated and participate treatment
Exclusion criteria
Main exclusioncriteria for the standard treatment are:
Pregnancy or intention to get pregnant within the treatment period + 6 months
no adequate contraception (for men and women)
HIV positivity
Active uncontrolled psychiatric disorders and suicidal leanings
patients with a history of uncontrolled seizure or other significant CNS dysfunction
Chemotherapy, systemic antiviral treatment during 6 months prior to study entry
Other serious disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-003404-19-NL |
| CCMO | NL12978.068.07 |