Rosuvastatin for Hepatitis C

Hepatitis C Clinical Trial

Official title:

Treatment With Rosuvastatin in Patients With Hepatitis C

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00371579
• Other study ID #: 06-125
• Status: Withdrawn
• Phase: N/A
• First received: September 1, 2006
• Last updated: June 2, 2015
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2009
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• rosuvastatin

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & 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. Epub 2005 Feb 7. — View 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. Epub 2003 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of serious side effects like rhabdomyolysis and hepatotoxicity during treatment
Primary	decrease of HCV-RNA viral load during treatment
Primary	decrease of LDL during treatment