EUCTR2007-003012-61-FR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)
sanofi-aventis Recherche & D2veloppement0 个研究点目标入组 720 人开始时间: 2007年11月26日最近更新:
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
- •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)
- •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
- •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. No history of or presence of overt diabetes (i.e., FPG < 126 ng/mL / 7.0 mmol/L)
- •4. Other cause of chronic liver disease and/or hepatic steatosis: Wilson’s Disease (i.e., evaluate ceruloplasmin), Alpha-1-Antitrypsin deficiency (i.e., evaluate alpha-1-antitrypsin), Viral hepatitis (i.e., evaluate serologies for Hepatitis B and C), Primary Biliary Cirrhosis (i.e., baseline liver biopsy NOT consistent with PBC and evaluate
- •antimitochondrial), Autoimmune hepatitis (i.e., baseline liver biopsy NOT consistent with autoimmune hepatitis and evaluate anti-smooth muscle antibody), Genetic iron overload (i.e., presence of 3-4+ stainable iron on baseline liver biopsy or known C282Y +/+), History of sleep apnea (unless on Constant Positive Airway Pressure therapy), History of or current HIV infection (i.e., evaluate anti-HIV), Hypo- or hyper-thyroidism (i.e., evaluate TSH)
- •5. Any contraindication to liver biopsy based on local standard for pre-liver biopsy risk
- •assessment (as examples,: presence of a bleeding dyscrasia, platelets < 50-75K, prothrombin time > 3 sec above control as measured locally during pre-biopsy evaluation of coagulation parameters)
- •6. History of or planned gastrointestinal bypass surgery/intervention (i.e., bariatric surgery)
- •7. Hepatic Cirrhosis with a Child-Pugh classification of B or C (score > 6)
- •8. 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)
- •9. Previous hepatic transplantation
- •10. Recent significant weight loss (> 5% TBW within previous 6 months)
- •11. ALT or AST > 10 x ULN at screening or within 3 months of screening
- •12. 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
- •13. Use of insulin, biguanide, sufonylurea or thiazolidinedione within last 6 months before baseline liver biopsy and screening visit
- •14. 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)
- •-pentoxyfilline
- •-angiotensin II inhibitor
- •15. Recent (within 3 months of baseline liver biopsy and screening visit) change in dose/ regimen or introduction of weight loss agent such as:
- •-sibutramine
- •- rimonabant
- •16. 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
- •17. Participation in any clinical study of an investigational agent within 30 days or five half-lives of the investigational agent, whichever is longer
- •18. Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological
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