| Trial ID: | L0346 |
| Source ID: | NCT02421094
|
| Associated Drug: |
GR-MD-02
|
| Title: |
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
|
| Acronym: |
NASH-FX
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT02421094/results
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: GR-MD-02|Drug: Placebo
|
| Outcome Measures: |
Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping (LiverMultiScan -LMS)|Baseline-adjusted Change in Liver Stiffness With MR-elastography (MRE)|Baseline-adjusted Change in Liver Stiffness by FibroScan??
|
| Sponsor/Collaborators: |
Galectin Therapeutics Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
30
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
September 2015
|
| Completion Date: |
September 27, 2016
|
| Results First Posted: |
September 28, 2020
|
| Last Update Posted: |
October 8, 2020
|
| Locations: |
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02421094
|
