Fatty Liver
Conditions
Keywords
NASH, chronic liver disease
Brief summary
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).
Detailed description
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
Interventions
DRUGRimonabant
Tablet, oral administration
Tablet, oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosis of NASH
Exclusion criteria
* Excessive alcohol use * Presence of diabetes mellitus * Other chronic liver disease * Previous or current hepatocellular carcinoma * Use of medication known to cause steatosis * Previous bariatric surgery * Pregnancy or breastfeeding * Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) | Baseline to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in hepatic fibrosis score | Baseline to 24 months |
| Change from baseline in serum hyaluronate (HA) | Baseline to 24 months |
| Change from baseline in hepatic transaminases (AST/ALT) | Baseline to 24 months |
Countries
Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Croatia, France, Germany, Hungary, Italy, Malaysia, Mexico, Philippines, Poland, Portugal, Puerto Rico, Romania, Spain, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed