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
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10053219Term: Non-alcoholic steatohepatitison diabetic patients with Non-Alcoholic Steato-Hepatitis (NASH)
- Registration Number
- EUCTR2007-003012-61-IT
- Lead Sponsor
- sanofi-aventis recherche & development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to demonstrate in patients without co-morbid diabetes following a minimum of 24 months treatment, the superiority of rimonabant 20 mg OD over placebo for improving the severity of NASH as measured by histological features of liver injury.;Secondary Objective: The secondary objectives of this study are to demonstrate in patients without co-morbid diabetes following a minimum of 24 months treatment, the superiority of rimonabant 20 mg OD over placebo: 1) In severity of hepatic fibrosis as measured by hepatic fibrosis stage; 2) In level of circulating plasma adiponectin; 3) In level of circulating hyaluronate; 4) In degree of insulin sensitivity; and, 5) In AST/ALT level.;Primary end point(s): The primary efficacy endpoint is the mean change per year in NAS (NAFLD Activity Score) between baseline and end of study biopsy evaluation
- Secondary Outcome Measures
Name Time Method