Non diabetic patients with Non-Alcoholic Steato-Hepatitis MedDRA version: 9.1 Level: LLT Classification code 10053219 Term: Non-alcoholic steatohepatitis
Conditions
Sponsors
sanofi recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: •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 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) -fibrate -statin -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: -orlistat -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 longe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 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. | — |
Countries
Belgium, France, Germany, Hungary, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed