EUCTR2007-003013-14-ES进行中（未招募）1 期
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)-------------------------------------------------------------------------------------------------------Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, de rimonabant 20 mg al día para el tratamiento de pacientes Diabéticos tipo II con Esteatohepatitis No alcohólica. - STRONG2
sanofi-aventis recherche & development0 个研究点目标入组 720 人开始时间: 2007年10月15日最近更新:
适应症
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
- 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
- •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
- •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. 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 > 8.5.
- •5. 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 (unless on Constant Positive Airway Pressure therapy)
- •- History of or current HIV infection
- •- Hypo- or hyper-thyroidism
- •6. 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)
- •7. History of or planned gastrointestinal bypass surgery/intervention (i.e., bariatric surgery)
- •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)
- •- 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
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