Hepatitis C Clinical Trial
Official title:
Treatment With Rosuvastatin in Patients With Hepatitis C
Objective: Determine if maximum doses of rosuvastatin are safe in patients infected with
hepatitis C and if the so called pleiotropic effects of rosuvastatin cause a decrease in the
HCV viral load.
Primary study parameters: 1. to which extend causes rosuvastatin serious side effects like
rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis C? 2. does
treatment with rosuvastatin in HCV infected patients lead to lower HCV-RNA viral load? 3. Is
a decrease in LDL correlated to a decrease in HCV-RNA load?
Study design: it's a pilot study in which the patients form their own control group. A total
of 10 patients will be included. To evaluate the effect of maximum doses of rosuvastatin on
liver function and side effects, first 2 patients will be treated and evaluated. If they
experience no serious adverse events then a further 8 patients will be included. The dose of
rosuvastatin will be increased over a period of 4 weeks.
Intervention: based on experience in treating dyslipidemia, gradually increasing the dose of
rosuvastatin diminishes the experienced side effects and decreases the chances of developing
hepatotoxicity. Therefore in this study we chose to increase the dose (see flowchart).
Patients will start with 5 mg a day wich will be increased after 1 week to 10 mg per day.
After the second week of therapy a further increase to 20 mg per day is executed. This dose
will be given for another 2 weeks. At week 4 of treatment a further increase to 40 mg is
done.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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