ISRCTN48248159
Completed
未知
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
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 sites72 target enrollmentMarch 27, 2008
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)
- Enrollment
- 72
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24118830
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Not specified
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