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| 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 |
| ISRCTN | ISRCTN48248159 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | HCV Lipid Study |
| Serial number at source | EudraCT: 2006-004335-29 |
| Study hypothesis |
Null hypotheses:
1. Omacor (low dose or high dose) treatment will have no effect on hepatitis C viral load 2. Fluvastatin treatment will have no effect on viral load |
| Ethics approval | Ethics approval received from the Fife and Forth Valley Research Ethics Committee on the 9th May 2007 (ref: 07/S0501/21). |
| Study design | Randomised open 3 x 2 factorial trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Chronic hepatitis C infection |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 01/12/2007 |
| Anticipated end date | 30/04/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 72 |
| Interventions |
Patients will be randomised to either:
Group 1: olive oil capsules daily for 12 weeks Group 2: omacor 1 g daily for 12 weeks Group 3: omacor 2 g daily for four weeks increasing to 1 g four times a day (q.d.s.) from weeks 5 - 12 Group 4: fluvastatin 40 mg daily for four weeks, then 80 mg daily from weeks 5 - 12, and olive oil capsules daily for 12 weeks Group 5: omacor 1 g daily for 12 weeks, combined with fluvastatin 40 mg daily for four weeks, then 80 mg daily from weeks 5 - 12 Group 6: omacor 2 g daily for four weeks combined with fluvastatin 40 mg daily for four weeks, then omacor 1 g q.d.s and fluvastatin 80 mg daily from weeks 5 - 12 |
| Primary outcome measure(s) |
1. Fall in ALT from pre-treatment (average of screening and baseline visits) to end of treatment (EOT)
2. Fall in HCV viral load (lipoviroparticle [LVP] = putative infectious virion and/or total HCV RNA) from pre-treatment (average of screening and baseline visits) to EOT |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Medical Research Council (UK) (grant ref: AW-67446; G0502028) |
| Trial website | |
| Publications | |
| Contact name | Prof Maggie Bassendine |
| Address |
Freeman Hospital
High Heaton |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE7 7DN |
| Country | United Kingdom |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Address |
Research and Development Department
4th Floor, Leazes Wing Royal Victoria Infirmary Queen Victoria Road |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 4LP |
| Country | United Kingdom |
| Sponsor website: | http://www.newcastle-hospitals.org.uk/ |
| Date applied | 13/11/2007 |
| Last edited | 28/04/2008 |
| Date ISRCTN assigned | 27/03/2008 |
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