Nonalcoholic Steatohepatitis
Conditions
Interventions
investigational material(s)
Generic name etc : DSP-1747
INN of investigational material : Obeticholic acid
Therapeutic category code : 391 Agents for liver disease
Dosage and Administration for Inves
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with Nonalcoholic Steatohepatitis based on the liver biopsy -Outpatients etc.
Exclusion criteria
Exclusion criteria: - Patients with significant alcohol consumption - Patients with complication by other chronic liver disease etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological improvement Last observation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in indicators of hepatic function Change in disease markers Last observation | — |
Outcome results
None listed