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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00371579
First Posted: September 4, 2006
Last Update Posted: June 3, 2015
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.
Information provided by:
UMC Utrecht
  Purpose

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?


Condition Intervention
Hepatitis C Drug: rosuvastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With Rosuvastatin in Patients With Hepatitis C

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • occurrence of serious side effects like rhabdomyolysis and hepatotoxicity during treatment
  • decrease of HCV-RNA viral load during treatment
  • decrease of LDL during treatment

Enrollment: 0
Study Start Date: October 2006
Estimated Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371579


Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: I.M. Hoepelman, Professor UMC Utrecht
Principal Investigator: H. Lokhorst, MD PhD UMC Utrecht
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00371579     History of Changes
Other Study ID Numbers: 06-125
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: June 3, 2015
Last Verified: February 2009

Keywords provided by UMC Utrecht:
rosuvastatin
hepatitis C
geranylgeranylation
HCV-RNA load

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents