A randomised, controlled, factorial pilot study investigating omacor and/or fluvastatin in patients with chronic hepatitis C who have not responded to standard combination anti-viral therapy

Not Applicable

Completed

• Conditions: Chronic hepatitis C infection; Infections and Infestations; Chronic viral hepatitis

• Registration Number: ISRCTN48248159
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24118830

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-27
• Study Completion: 2010-04-30
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Age greater than or equal to 18 years
2. Positive hepatitis C ribonucleic acid (RNA) for more than six months
3. Elevated serum alanine transaminase (ALT) above normal limits for each laboratory
4. Previous lack of sustained virological response (SVR) to treatment with standard combination anti-viral therapy (standard interferon alpha and ribavirin and/or pegylated interferon alpha and ribavirin)
5. No lipid modulating agents for at least three months
6. Negative urine pregnancy test (for women of child bearing potential) documented within the 48 hour period prior to the first dose of test drug

Additionally all subjects must ensure adequate contraception during and for one month after treatment.

Exclusion Criteria

1. Hepatitis B virus (HBV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) co-infection
2. A medical condition associated with chronic liver disease other than viral hepatitis, specifically excluding non-alcoholic fatty liver disease by body mass index (BMI) greater than or equal to 30
3. Clinical evidence of decompensated cirrhosis (ascites, portal hypertension with grade 2 oesophageal varices, hepatocellular cancer)
4. Alcohol use in excess of safe limits (28 units per week for men and 21 units per week for women)
5. Unable to conform to study protocol due to alcohol misuse or drug abuse
6. Serum alphafoetoprotein greater than or equal to 100
7. Platelet count less than 60,000 cells per/ml
8. Any research study within previous three months
9. Severe seizure disorder or concurrent phenytoin use
10. Lactation
11. History of muscular toxicity secondary to statins or fibrates
12. Hereditary muscle disorder or family history of hereditary muscle disorder
13. Concurrent anti-coagulant use

Study & Design

• Study Type: Interventional
• Study Design: Not specified