NCT00371579

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. 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?

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 3, 2015

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

September 1, 2006

Last Update Submit

June 2, 2015

Conditions

Hepatitis C

Keywords

rosuvastatinhepatitis CgeranylgeranylationHCV-RNA load

Outcome Measures

Primary Outcomes (3)

  • occurrence of serious side effects like rhabdomyolysis and hepatotoxicity during treatment

  • decrease of HCV-RNA viral load during treatment

  • decrease of LDL during treatment

Interventions

rosuvastatinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • Kapadia SB, Chisari FV. Hepatitis C virus RNA replication is regulated by host geranylgeranylation and fatty acids. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2561-6. doi: 10.1073/pnas.0409834102. Epub 2005 Feb 7.

    PMID: 15699349BACKGROUND

  • Ye J, Wang C, Sumpter R Jr, Brown MS, Goldstein JL, Gale M Jr. Disruption of hepatitis C virus RNA replication through inhibition of host protein geranylgeranylation. Proc Natl Acad Sci U S A. 2003 Dec 23;100(26):15865-70. doi: 10.1073/pnas.2237238100. Epub 2003 Dec 10.

    PMID: 14668447BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • I.M. Hoepelman, Professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • H. Lokhorst, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 3, 2015

Record last verified: 2009-02

Locations

NL(1)