ISRCTN48248159已完成未知
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 个研究点目标入组 72 人开始时间: 2008年3月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24118830
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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