Chronic Hepatitis C Infection MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Trade Name: Omacor
Pharmaceutical Form: Capsule, soft
Trade Name: Lescol
Pharmaceutical Form: Capsule, hard
Sponsors
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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) • Fall in ALT at EOT | — |
Countries
United Kingdom
Outcome results
None listed