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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48248159 |
| EudraCT/CTIS number | 2006-004335-29 |
| Secondary identifying numbers | MRC ref: G0502028; EudraCT: 2006-004335-29 |
- Submission date
- 13/11/2007
- Registration date
- 27/03/2008
- Last edited
- 22/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Maggie Bassendine
Scientific
Scientific
Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study information
| Study design | Randomised open 3 x 2 factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | HCV Lipid Study |
| Study objectives | 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(s) | Ethics approval received from the Fife and Forth Valley Research Ethics Committee, 09/05/2007, ref: 07/S0501/21 |
| Health condition(s) or problem(s) studied | Chronic hepatitis C infection |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omacor, fluvastatin |
| Primary outcome measure | 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 measures | No secondary outcome measures |
| Overall study start date | 01/12/2007 |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/12/2007 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
4th Floor, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Research council
Medical Research Council (UK) (grant ref: AW-67446; G0502028)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | Yes | No |
Editorial Notes
22/02/2019: Publication reference added.
18/07/2016: No publications found, verifying study status with principal investigator.
