EUCTR2009-015166-62-GB进行中（未招募）1 期
A randomised controlled trial of Losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis. - Fibrosis Effects of Losartan in Nash Evaluation Study- FELINE
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 45 人开始时间: 2010年10月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adults (aged 18+ years), with steatohepatitis and fibrosis (Kleiner F1-F3), resulting from non-alcoholic fatty liver disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 214
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. refusal or inability (lack of capacity) to give informed consent 2. average alcohol ingestion more than 21 units per week (males) or more than 14 units per week (females) 3. history or presence of Type 1 diabetes mellitus 4. haemoglobin A1C >15.0 5. other causes of chronic liver disease or hepatic steatosis 6. any contra-indication to liver biopsy 7. history of or planned gastrointestinal bypass surgery 8. hepatocellular carcinoma 9. previous liver transplant 10. recent significant weight loss (more than 5% total body weight within last 6 months) 11. electrolyte disturbance: potassium level outside the normal (local) range. 12. ALT or AST > 10 x ULN at screening 13. recent (within six months of baseline liver biopsy and screening visit) or concomitant use of agent known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid), or concomitant use of pioglitazone, fluconazole, rifampicin or any drug contra-indicated in the Losartan Summary of Product Characteristics (SmPC) 14. Introduction of metformin, glitazones, a GLP-1 agonist, Vitamin E or C, betaine, s-adenosyl methionine, ursedeoxycholic acid, silymarin, fibrate, pentoxifylline, orlistat, sibutramine or rimonabant within 3 months of baseline liver biopsy and screening visit. 15. intolerance of ARBs or presence of multiple allergic reactions to drugs 16. use of ACE inhibitor or ARB in previous year 17. hypotension (Systolic less than 100, diastolic less than 60) 18. renal failure (Cr >130) 19. participation in any clinical study of an investigational medicinal product (IMP) within 30 days or five half-lives of the IMP, whichever is longer 20. presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, renal, hepatic, metabolic, haematological, neurological, psychiatric, systemic, ocular, gynaecological or any acute infectious disease or signs of acute illness that, in the opinion of the investigator, might compromise the patient’s safe participation in the trial 21. presence or history of cancer within the past five years, with exception of adequately-treated localised basal cell carcinoma of the skin, in situ cervical carcinoma or solid malignancy surgically excised in toto without recurrence for five years 22. women of child-bearing potential not protected by effective contraceptive method of birth control or surgical sterilization, and/or who are unwilling or unable to be tested for pregnancy (Pregnancy status will be checked by serum pregnancy testing before initiation of study treatment and by urine pregnancy testing during the trial) 23. known allergy or sensitivity to Losartan or its excipients (microcrystalline cellulose (E460); lactose monohydrate; pregelatinized maize starch; magnesium stearate (E572); hydroxypropyl cellulose (E463); hypromellose (E464))
研究者
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