Rosuvastatin for Hepatitis C - Full Text View

Sponsored by:	UMC Utrecht
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00371579

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

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Treatment With Rosuvastatin in Patients With Hepatitis C

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

Estimated Enrollment:	10
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2007

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371579

Contacts

Contact: J.E. Arends, MD	+31302506228	j.e.arends@umcutrecht.nl
Contact: E van der Spek, MD	+31302507655	e.vanderspek@umcutrecht.nl

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:

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. Epub 2005 Feb 7.

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. Epub 2003 Dec 10.

Study ID Numbers:	06-125
Study First Received:	September 1, 2006
Last Updated:	September 1, 2006
ClinicalTrials.gov Identifier:	NCT00371579
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

rosuvastatin
hepatitis C
geranylgeranylation
HCV-RNA load

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Rosuvastatin

Digestive System Diseases
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

Antimetabolites
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Therapeutic Uses

Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009