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Rosuvastatin for Hepatitis C

This study has been withdrawn prior to enrollment.
(no actual patients recruited within year 1 after ethical committee approval)
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00371579
First received: September 1, 2006
Last updated: February 12, 2009
Last verified: February 2009

September 1, 2006
February 12, 2009
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 ClinicalTrials.gov 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.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
10
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00371579
06-125
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UMC Utrecht
Not Provided
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