| Trial ID: | L0423 |
| Source ID: | NCT04501406
|
| Associated Drug: |
Pioglitazone
|
| Title: |
Effect of Low-Dose Pioglitazone in Patients With Nonalcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM);Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Pioglitazone;Other: Placebo
|
| Outcome Measures: |
The proportion of pioglitazone-treated patients relative to placebo achieving an improvement of =2 points in non-alcoholic fatty liver disease activity score (NAS) without an increase in fibrosis stage.Resolution of NASH without worsening of liver fibrosis.;Proportion of patients with improvement in the activity component of steatosis-activity-fibrosis (SAF) score.;Proportion of patients with NAS improvement (0-8).;Mean NAS change (0-8).;Proportion of patients with a change of the individual components of the NAS score (steatosis, lobular inflammation and ballooning) by at least 1 point.;Mean change of the individual components of the NAS;Fibrosis improvement.;Improvement of fibrosis by at least 2 stages.;Improvement of fibrosis AND resolution of NASH as a composite endpoint.;No worsening of fibrosis AND no worsening of NASH;Progression of liver fibrosis.;Mean change in liver fibrosis
|
| Sponsor/Collaborators: |
University of Florida
|
| Gender: |
All
|
| Age: |
21 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
138
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
03/08/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
25 January 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04501406
|
