Rosuvastatin for Hepatitis C

• Status: Withdrawn
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

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?

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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