Status:
WITHDRAWN
Rosuvastatin for Hepatitis C
Lead Sponsor:
UMC Utrecht
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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. P...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- age between 18 and 65 years
- All patients with hepatitis C (all genotypes)
- negative for hepatitis B and HIV
- ALAT \< 2,5 x below the upper limit of normal
- serological evidence of hepatitis C infection with detectable HCV-RNA (with Bayer Versant HCV bDNA V3.0)
- failed current standard of care treatment with peginterferon and ribavirin
- WHO-score ≤1
- fertile women must have a negative pregnancy test in the week before start of medication. Use of contraceptives during the whole study-period
- physically and mentally able to attend outpatients clinics
Exclusion
- Hepatitis C patiënts naive for (peg)interferon and ribavirin treatment
- Alcohol abuses (\> 20 grams per day) in the last year
- liver cirrhosis detected through liver biopsy or decompensated liver disease (child-pugh B or C)
- concomitant treatment with hepatotoxic medication / interfering with CYP450 system: anti-fungal medication (voriconazole), antibiotics (gentamycine, azitromycine, claritromycin, erytromycin), immuun-suppresive drugs (cyclosporine), anti-arythmia (diltiazem, verapamil) and tuberculostatic drugs (rifampicin).
- current statin use
- active pregnancy or wish of pregnangy
- use of grapefruit juice
- mentally not fit to participate in the study
- daily use of more than 2 grams of paracetamol
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00371579
Start Date
October 1 2006
End Date
October 1 2007
Last Update
June 3 2015
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX