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