EUCTR2007-003012-61-IT进行中（未招募）不适用
A double-blind, randomized, placebo-controlled, parallel group study of rimonabant 20 mg daily for the treatment of non-diabetic patients with nonalcoholic steatohepatitis (NASH)</ - STRONG
sanofi-aventis recherche & development0 个研究点目标入组 720 人开始时间: 2007年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 720
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
- 性别
- All
入选标准
- •Non diabetic patients with Non-Alcoholic Steato-Hepatitis
- •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
排除标准
- •Exclusion criteria related to study methodology - Refusal or inability to give informed consent to participate in the study - Average alcohol ingestion > 21 units/wk (males) or > 14 units/wk (females) - No history of or presence of overt diabetes -Other cause of chronic liver disease and/or hepatic steatosis: −Wilson?s Disease −Alpha-1-Antitrypsin deficiency −Viral hepatitis −Primary Biliary Cirrhosis −Autoimmune hepatitis −Genetic iron overload −History of sleep apnea −History of or current HIV infection −Hypo- or hyper-thyroidism -Any contraindication to liver biopsy based on local standard for pre-liver biopsy risk assessment -History of or planned gastrointestinal bypass surgery/intervention -Hepatic Cirrhosis with a Child-Pugh classification of B or C - Concomitant Hepatocellular Carcinoma (HCC) -Previous hepatic transplantation -Recent significant weight loss -ALT or AST > 10 x ULN at screening or within 3 months of screening -Recent or concomitant use of agent known to cause hepatic steatosis: −corticosteroids −amiodarone −methotrexate −tamoxifen −tetracycline −high dose estrogens −valproic acid - Use of insulin, biguanide, sufonylurea or thiazolidinedione within last 6 months before baseline liver biopsy and screening visit -Recent change in dose/ regimen or introduction of: −Vitamin E, Vitamin C −betaine, s-adenosyl methionine , ursodeoxycholate −silymarin −fibrate −statin −pentoxyfilline −angiotensin II inhibitor -Recent change in dose/ regimen or introduction of weight loss agent such as: −orlistat −sibutramine - rimonabant -Any situation that in the Investigator?s opinion, may interfere with optimal study participation -Participation in any clinical study of an investigational agent -Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or any acute infectious disease or signs of acute illness -Presence or history of multiple allergic reactions to drugs -Presence or history of cancer within past 5 years with exception of adequately treated localized basal cell carcinoma of the skin, in situ cervical cancer or solid malignancy surgically excised in toto without recurrence for five years -Women of childbearing 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. -Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Exclusion criteria related to the sanofi-aventis compound -Be pregnant or breastfeeding -Hypersensitivity to rimonabant or to any of the excipients.
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