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. - HCV lipid study

Phase 1

Conditions: Chronic Hepatitis C Infection
MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

Registration Number: EUCTR2006-004335-29-GB

Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Age=18 years
2.Positive Hepatitis C RNA for more than 6 months
3.Elevated serum alanine transaminase (ALT)
4.Previous lack of response to treatment with standard combination anti-viral therapy (Standard interferon a and Ribavirin and/or Pegylated interferon a and Ribavirin)
5.No lipid modulating agents for at least 3 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.HBV, HDV or 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) = 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 = 100
7.Platelet count < 60,000 cells per/ml
8.Any research study within previous 3 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether fish oils (omacor) and/or Fluvastatin as monotherapy and combination therapy shows a trend towards efficacy in patients with chronic hepatitis C who have not had a sustained virological response (SVR) to standard combination therapy (non-responders).<br><br>To gain an understanding of the relationship between lipid and meatabolic parameters and hepatitis c viral replication in subjects receiving these lipid-modulating agents.;Secondary Objective: ;Primary end point(s): •Fall in HCV viral load [LVP = putative infectious virion and/or total HCV RNA] at end of treatment (EOT)<br>•Fall in ALT at EOT<br>

Secondary Outcome Measures