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)
- Conditions
- on diabetic patients with Non-Alcoholic Steato-HepatitisMedDRA version: 9.1Level: LLTClassification code 10053219Term: Non-alcoholic steatohepatitis
- Registration Number
- EUCTR2007-003012-61-FR
- Lead Sponsor
- sanofi-aventis Recherche & D2veloppement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
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 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)
-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 longer
18. Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method