ISRCTN57849521已完成3 期
A randomised controlled trial of losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 214 人开始时间: 2009年10月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 16/06/2011:
- •Adults (both males and females, aged 18+) with steatohepatitis and fibrosis (Kleiner F1-F3), resulting from non-alcoholic fatty liver disease
- •Previous inclusion criteria:
- •Adults (both males and females, aged 18+) with fibrosis resulting from non-alcoholic steatohepatitis.
排除标准
- •Current exclusion criteria as of 09/07/2012:
- •1. Refusal or inability (lack of capacity) to give informed consent
- •2. Average alcohol ingestion >21 units/week (males) or >14 units/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 transplantation
- •10. Recent significant weight loss (>5% total body weight within last 6 months)
- •11. Electrolyte disturbance: potassium level outside the normal (local) range.
- •12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN) at screening
- •13. Recent (within 6 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 SmPC.
- •14. Introduction of metformin, glitazones, a GLP-1 agonist, Vitamin E or C, betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin, fibrate, pentoxifylline, orlistat, sibutramine or rimonabant within 3 months of baseline liver biopsy and screening visit.
- •15. Intolerance of angiotensin receptor blockers (ARBs) or presence of multiple allergic reactions to drugs
- •16. Use of angiotensin-converting enzyme (ACE) inhibitor or ARB in previous year
- •17. Hypotension (systolic <100, diastolic <60)
- •18. Renal failure (Cr >130)
- •19. Participation in any clinical study of an investigational agent within 30 days or five half-lives of the investigational product, whichever is longer
- •20. Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, renal, hepatic, metabolic, haematological, neurological, psychiatric, systemic, ocular, gynaecologic 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 5 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; pregelaatinized maize starch; magnesium stearate [E572]; hydroxypropyl cellulose [E463]; hypromellose [E464])
- •Previous exclusion criteria until 09/07/2012:
- •4. Haemoglobin A1C>9.0
- •14. Recent (within 3 months of baseline liver biopsy and screening visit) change in anti-diabetes treatment or change in dose or regimen, or introduction of Vitamin E or C, betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin, fibrate, pentoxifylline, orlistat, sibutramine or rimonabant.
- •Previous exclusion criteria:
- •4. Haemoglobin A1C >8.5
- •12. Recent (within 6 months of baseline liver biopsy and screening visit) or concomitant use of a
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