| Trial ID: | L0210 |
| Source ID: | NCT04521114
|
| Associated Drug: |
Leronlimab
|
| Title: |
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis(NASH)
|
| Acronym: |
--
|
| Status: |
Active, not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: Placebos|Drug: leronlimab
|
| Outcome Measures: |
Change from baseline in hepatic fat fraction assessed by magnetic resonance imaging-derived protondensity fat fraction (MRI-PDFF) at week 14|Change from baseline in cT1 (or corrected T1) assessed by multiparametric magnetic resonanceimaging (MRI) of liver at week 14|Change from baseline in liver fibrosis using FibroTest at week 14|Change from baseline in hepatic inflammatory activity using FibroTest at week 14|Change from baseline in serum pro-inflammatory biomarkers including IL-1 alpha, IL-1 beta, IL-6, RANTES (CCL5), TNF-alpha, TNF-beta, and CRP|Change from baseline in Gamma-glutamyltransferase (GGT) at week 14|Change from baseline in Cytokeratin 18 (CK-18) level at week 14
|
| Sponsor/Collaborators: |
CytoDyn, Inc.|Amarex Clinical Research
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
December 1, 2020
|
| Completion Date: |
July 22, 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 14, 2022
|
| Locations: |
Meridien Research, Maitland, Florida, United States|Floridian Clinical Research, Miami Lakes, Florida, United States|Center for Advanced Research & Education, Gainesville, Georgia, United States|American Research Corporation, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04521114
|
