Rosuvastatin for Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371579
Recruitment Status : Withdrawn (no actual patients recruited within year 1 after ethical committee approval)
First Posted : September 4, 2006
Last Update Posted : June 3, 2015
Information provided by:
UMC Utrecht

September 1, 2006
September 4, 2006
June 3, 2015
October 2006
October 2007   (Final data collection date for primary outcome measure)
  • occurrence of serious side effects like rhabdomyolysis and hepatotoxicity during treatment
  • decrease of HCV-RNA viral load during treatment
  • decrease of LDL during treatment
Same as current
Complete list of historical versions of study NCT00371579 on Archive Site
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Rosuvastatin for Hepatitis C
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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C
Drug: rosuvastatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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UMC Utrecht
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Principal Investigator: I.M. Hoepelman, Professor UMC Utrecht
Principal Investigator: H. Lokhorst, MD PhD UMC Utrecht
UMC Utrecht
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP