| Trial ID: | L0353 |
| Source ID: | NCT03656068
|
| Associated Drug: |
Nitazoxanide
|
| Title: |
An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis|Fatty Liver|Fibrosis, Liver|Compensated Cirrhosis
|
| Interventions: |
Drug: Nitazoxanide 500mg BID
|
| Outcome Measures: |
Number of participants with treatment related adverse events and serious adverse events|Percent change in Fractional Synthesis Rate (FSR) from baseline to end of treatment evaluated through the use of deuterated water.|Change in liver stiffness from baseline to end or treatment as evaluated by FibroScan??|Change in liver stiffness from baseline to end of treatment as evaluated through the use Magnetic Resonance Elastography (MRE)|Change in Fibrosis-4 (FIB-4) serum biomarker at baseline to 12 weeks treatment and 24 weeks of treatment|Change in NAFLD Fibrosis Score at baseline to 12 weeks to 24 weeks|Change in Enhanced Liver Fibrosis (ELF) Score (ELFTM) at baseline to 12 weeks to 24 weeks|Change in non-invasive markers of fibrosis at baseline to 12 weeks to 24 weeks
|
| Sponsor/Collaborators: |
Pinnacle Clinical Research, PLLC
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
16
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
|
| Start Date: |
December 15, 2018
|
| Completion Date: |
November 25, 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 29, 2021
|
| Locations: |
Pinnacle Clinical Research, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03656068
|
