| Trial ID: | L0227 |
| Source ID: | NCT04255069
|
| Associated Drug: |
JKB-122
|
| Title: |
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
|
| Interventions: |
Drug: Placebo|Drug: Dose 1 JKB-122|Drug: Dose 2 JKB-122
|
| Outcome Measures: |
To evaluate the effect of JKB-122 compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis|To evaluate the effect of JKB-122 compared to placebo to achieve a ??? 1 stage fibrosis improvement on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis|Evaluate the changes of hepatic fat content|Evaluate the changes of fibrosis score
|
| Sponsor/Collaborators: |
TaiwanJ Pharmaceuticals Co., Ltd
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
300
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
June 30, 2020
|
| Completion Date: |
December 31, 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
February 13, 2020
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT04255069
|
