Condition category
Infections and Infestations
Date applied
13/11/2007
Date assigned
27/03/2008
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maggie Bassendine

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2006-004335-29

ClinicalTrials.gov number

Protocol/serial number

MRC ref: G0502028; EudraCT: 2006-004335-29

Study information

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

Acronym

HCV Lipid Study

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, 09/05/2007, ref: 07/S0501/21

Study design

Randomised open 3 x 2 factorial trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Omacor, fluvastatin

Primary outcome measures

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 trial start date

01/12/2007

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant 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

Recruitment start date

01/12/2007

Recruitment end date

30/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
4th Floor
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (grant ref: AW-67446; G0502028)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.