NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1041190098

Registered date:17/12/2019

The effect of pemafibrate in improving liver fibrosis in nonalcoholic fatty liver disease

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNon alcoholic steatohepatitis
Date of first enrollment01/12/2019
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Administration of Pemafirate 0.2 mg per day for 48 weeks

Outcome(s)

Primary OutcomeImprovement of FIB-4 index after treatment
Secondary Outcome1. 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Hidenao Noritake
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan Shizuoka Japan 431-3192
Telephone +81-53-435-2263
E-mail noritake@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine
Scientific contact
Name Kazuhito Kawata
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan Shizuoka Japan 431-3192
Telephone +81-53-435-2263
E-mail kawata@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine