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Rosuvastatin for Hepatitis C

Primary Purpose

Hepatitis C

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring rosuvastatin, hepatitis C, geranylgeranylation, HCV-RNA load

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Utrecht

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
September 1, 2006
Last Updated
June 2, 2015
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT00371579
Brief Title
Rosuvastatin for Hepatitis C
Official Title
Treatment With Rosuvastatin in Patients With Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Why Stopped
no actual patients recruited within year 1 after ethical committee approval
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht

4. Oversight

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
rosuvastatin, hepatitis C, geranylgeranylation, HCV-RNA load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Primary Outcome Measure Information:
Title
occurrence of serious side effects like rhabdomyolysis and hepatotoxicity during treatment
Title
decrease of HCV-RNA viral load during treatment
Title
decrease of LDL during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I.M. Hoepelman, Professor
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. Lokhorst, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
15699349
Citation
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.
Results Reference
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PubMed Identifier
14668447
Citation
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.
Results Reference
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Rosuvastatin for Hepatitis C

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