| Trial ID: | L0188 |
| Source ID: | NCT01899859
|
| Associated Drug: |
GR-MD-02
|
| Title: |
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: GR-MD-02|Drug: Placebo
|
| Outcome Measures: |
Primary objective is to characterize safety for GR-MD-02 administered intravenously to subjects w/ biopsy-proven NASH w/ advanced liver fibrosis. Specifically assessed by number of subjects experiencing TEAEs.|A secondary objective is to characterize the first-dose PK profile of GR-MD-02. The PK profile is assessed by the AUC (area under the plasma concentration versus time curve) and Cmax (peak plasma concentration) of GR-MD-02.|A secondary objective for the study is to characterize the PK profile and serum level accumulation of GR-MD-02 following administration of 3 subsequent weekly doses given by IV infusion beginning 28 days after the first dose.|A secondary objective is to evaluate change in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), ratio of AST:ALT, alkaline phosphatase, and gamma glutamyl transpeptidase (GGTP); change in AST/platelet ratio index.|A secondary objective for this study is to evaluate changes in exploratory pharmacodynamic biomarkers in serum
|
| Sponsor/Collaborators: |
Galectin Therapeutics Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 74 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
31
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
July 2013
|
| Completion Date: |
February 2015
|
| Results First Posted: |
--
|
| Last Update Posted: |
February 23, 2015
|
| Locations: |
Brooke Army Medical Ctr., San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT01899859
|
