Non alcoholic steatohepatitis
Conditions
Interventions
Administration of Pemafirate 0.2 mg per day for 48 weeks
Sponsors
Kawata Kazuhito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Twenty years old or more 2. Detected fatty liver by imaging (e.g. ultrasonography, composed tomography, magnetic resonance imaging) 3. Serum ALT > 31 U/L 4. Fasting serum triglyceride > 150 mg/dL or serum high-density lipoprotein cholesterol < 40 mg/dL 5. Written informed consent was obtained from the patient
Exclusion criteria
Exclusion criteria: 1. Alcohol habitual consumption 2. Anti-HCV positive or HBs-antigen positive 3. Autoimmune hepatitis or primary biliary cholangitis 4. Wilson's disease or hemochromatosis 5. Past history of coronary disease 6. Hyperlipidemia (triglyceride > 500 mg/dL) 7. Uncontrollable plasma glucose 8. Cirrhosis 9. Biliary obstruction 10. Moderate or severe renal function disorder 11. Galle stone 12. Familial hyperlipidemia 13. Corticosteroid or anti-estrogen 14. Cyclosporin or rifampicin 15. Allergy for pemafibrate 16. Expecting mother 17. Considered as inadequacy for this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of FIB-4 index after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Type 4 collagen 2. NFS score 3. Liver stiffness measured by MR elastography 4. Liver fat content measured by photo density fat fraction 5. Serum AST, ALT and gamma GT 6. Serum cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol 7. Plasma glucose and HbA1c 8. Bodyweight 9. Adverse event | — |
Contacts
Public ContactHidenao Noritake
Hamamatsu University School of Medicine
Outcome results
None listed