| Trial ID: | L0445 |
| Source ID: | JPRN-jRCT1041190098
|
| Associated Drug: |
Pemafibrate
|
| Title: |
A multicenter pre- and post-comparison study regarding the effect of pemafibrate in improving liver fibrosis in nonalcoholic fatty liver disease with dyslipidemia
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non alcoholic steatohepatitis
|
| Interventions: |
Administration of Pemafirate 0.2 mg per day for 48 weeks
|
| Outcome Measures: |
Improvement of FIB-4 index after treatment1. 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
|
| Sponsor/Collaborators: |
Kawata Kazuhito
|
| Gender: |
All
|
| Age: |
>= 20age oldNot applicable
|
| Phases: |
Not applicable
|
| Enrollment: |
20
|
| Study Type: |
Interventional
|
| Study Designs: |
single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
|
| Start Date: |
17/12/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
10 January 2022
|
| Locations: |
Japan
|
| URL: |
https://jrct.niph.go.jp/latest-detail/jRCT1041190098
|