A double-blind, randomized, placebo-controlled, parallel group study of rimonabant 20 mg daily for the treatment of Type 2 diabetic patients with nonalcoholic steatohepatitis (NASH)

sanofi-aventis recherche & development0 个研究点目标入组 720 人开始时间: 2007年9月17日最近更新: 2013年10月21日

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

研究概览入排标准研究者记录与标识符相似试验

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

•1. Patients who are at least 18 years of age and with a diagnosis of NASH by liver biopsy performed within last 6 months (based on pre-defined histological criteria as confirmed by a central pathologist)
•2. Confirmed Type 2 DM diagnosed by fasting plasma glucose = 126 mg/dl or 2-hour post load glucose = 200 mg/dl during an OGTT (equivalent of 75 g anhydrous glucose in water) of at least 6 months duration.
•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

•Related to study methodo
•1.Refusal or inability to give informed consent to participate in the study
•2.Average alcohol ingestion > 21 units/wk (males) or > 14 units/wk (females) [self administered quantity-frequency and 7-day recall tests and confirmed by a family member]
•3.History of or presence of Type 1 diabetes mellitus (requirement for insulin replacement and presence of autoantibodies, e.g., antipancreatic islet cell, insulin autoantibodies, tyrosine phosphate autoantibodies or GADAb)
•4.Hemoglobin A1C >9.0
•5.Other cause of chronic liver disease and/or hepatic steatosis (see protocol)
•6.Any contraindication to liver biopsy based on local standard for pre-liver biopsy risk assessment (for examples: see protocol)
•7.History of or planned gastrointestinal bypass surgery/intervention
•8.Hepatic Cirrhosis with a Child-Pugh classification of B or C (score > 6)
•9.Concomitant Hepatocellular Carcinoma (HCC) (i.e., AFP > 100 ng/mL on screening Liver Disease Panel or otherwise unexplained liver mass visualized on ultrasound or computed tomography examination of the liver)
•10.Previous hepatic transplantation
•11.Recent significant weight loss (> 5% TBW within previous 6 months)
•12.ALT or AST > 10 x ULN at screening or within 3 months of 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 estrogens (standard HRT and oral contraceptive doses allowed), valproic acid. 14.Recent (within 3 months of baseline liver biopsy and screening visit) change in anti-diabetes treatment, such as a change in dose-regimen of anti-diabetes agent or introduction of new- antidiabetes agent (a specific diabetes medication /treatment page will be included in the CRF).
•15.Recent (within 3 months of baseline liver biopsy and screening visit) change in dose/ regimen or introduction of: Vitamin E, Vitamin C, betaine, s-adenosyl methionine (SAM), ursodeoxycholate (UDCA), silymarin (silybin), fibrate, statin, pentoxyfilline, angiotensin II inhibitor 16.Recent (within 3 months of baseline liver biopsy and screening visit) change in dose/ regimen or introduction of weight loss agent such as: orlistat, sibutramine, rimonabant.
•17.Any situation that in the Investigator’s opinion, may interfere with optimal study participation such as alcohol or drug abuse, domicile too distant from study site, potential non-compliance during the study or inability to cooperate because of a language problem or poor mental development
•18.Participation in any clinical study of an investigational agent within 30 days or five half-lives of the investigational agent, whichever is longer
•19.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 that, in the opinion of the Investigator, might compromise the patient’s safe participation in this trial, , including uncontrolled serious psychiatric illness such as major depression within the last 2 years, suicidal ideation of Type 4(1) or Type 5(2) on the C-SSRS or suicidal behavior within the last month, medical history of suicide attempt and history of other severe psychiatric disorder (eg, schizophrenia or bipolar disorder). Any patient who scores 15 or higher on the PHQ-9 administ

研究者

发起方

sanofi-aventis recherche & development

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