| Trial ID: | L0197 |
| Source ID: | NCT02510599
|
| Associated Drug: |
Solithromycin
|
| Title: |
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: solithromycin
|
| Outcome Measures: |
To evaluate effects on hepatic histology in patients with NASH|Changes in Steatosis on liver biopsy|Changes in hepatocellular ballooning score on liver biopsy|Changes in inflammation on liver biopsy
|
| Sponsor/Collaborators: |
Melinta Therapeutics, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
10
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
December 2015
|
| Completion Date: |
February 28, 2017
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 21, 2017
|
| Locations: |
Case Western University Hospitals, Cleveland, Ohio, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02510599
|
