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
Clinical Trials Information System (CTIS)	2006-004335-29
Protocol serial number	MRC ref: G0502028; EudraCT: 2006-004335-29
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder	Medical Research Council (UK) (grant ref: AW-67446; G0502028)

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

Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised open 3 x 2 factorial trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Omacor, fluvastatin
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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Freeman Hospital

Newcastle upon Tyne
NE7 7DN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.