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

JRCT ID: jRCT1041190098

Registered date:17/12/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non alcoholic steatohepatitis
• Date of first enrollment: 01/12/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of Pemafirate 0.2 mg per day for 48 weeks

Outcome(s)

• Primary Outcome: Improvement of FIB-4 index after treatment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kawata Kazuhito