| Trial ID: | L0148 |
| Source ID: | NCT03868566
|
| Associated Drug: |
SNP-612
|
| Title: |
An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD
|
| Acronym: |
--
|
| Status: |
Unknown status
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: SNP-612 dose1|Drug: SNP-612 dose2|Drug: SNP-612 dose3|Drug: SNP-612 placebo
|
| Outcome Measures: |
Change in serum ALT|Change in serum AST|Change in serum Alk-P|Change in serum ??-GT|Change in GSP|Change in liver fat content as measured by liver fat fraction (FF) with magnetic resonance imaging method.|Change in serum CK-18 fragment levels|Rate of AE/SAE|Rate of AEs leading to discontinuation at end of treatment
|
| Sponsor/Collaborators: |
Sinew Pharma Inc.
|
| Gender: |
All
|
| Age: |
20 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
72
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
August 4, 2017
|
| Completion Date: |
December 31, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
February 21, 2020
|
| Locations: |
Tri-Service General Hospital, Taipei, Taiwan
|
| URL: |
https://ClinicalTrials.gov/show/NCT03868566
|