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

Not Applicable

Recruiting

• Conditions: on alcoholic steatohepatitis

• Registration Number: JPRN-jRCT1041190098
• Lead Sponsor: Kawata Kazuhito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of FIB-4 index after treatment

Secondary Outcome Measures

Name	Time	Method
1. Type 4 collagen<br>2. NFS score<br>3. Liver stiffness measured by MR elastography<br>4. Liver fat content measured by photo density fat fraction<br>5. Serum AST, ALT and gamma GT<br>6. Serum cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol<br>7. Plasma glucose and HbA1c<br>8. Bodyweight<br>9. Adverse event