Trial ID: | L0105 |
Source ID: | NCT02927314
|
Associated Drug: |
CF102
|
Title: |
A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease
|
Acronym: |
--
|
Status: |
Completed
|
Study Results: |
No Results Available
|
Results: |
--
|
Conditions: |
Non-alcoholic Steatohepatitis (NASH)
|
Interventions: |
Drug: CF102|Drug: Placebo
|
Outcome Measures: |
Efficacy of CF102 as determined by change in serum alanine aminotransferase (ALT) levels|Efficacy of CF102 as determined by change in magnetic resonance imaging-determined hepatic steatosis|Body weight in subjects with NAFLD|Waist circumference in subjects with NAFLD|HDL cholesterol levels in subjects with NAFLD|Normalization of serum ALT levels in subjects with NAFLD|Serum aspartate aminotransaminase (AST) levels in subjects with NAFLD|Hemoglobin A1c levels and degree of insulin resistance|Pharmacokinetics (PK) of CF102 in this population|Peripheral blood expression of the A3 adenosine receptor (A3AR).|Nature, frequency, and severity of adverse events in this patient population
|
Sponsor/Collaborators: |
Can-Fite BioPharma
|
Gender: |
All
|
Age: |
18 Years and older ?? (Adult, Older Adult)
|
Phases: |
Phase 2
|
Enrollment: |
60
|
Study Type: |
Interventional
|
Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
Start Date: |
November 27, 2017
|
Completion Date: |
March 1, 2020
|
Results First Posted: |
--
|
Last Update Posted: |
March 17, 2020
|
Locations: |
Can-Fite Investigational Site #318, Jerusalem, Israel|Can-Fite Investigational Site #319, Nazareth, Israel|Can-Fite Investigational Site #311, Petach Tikva, Israel
|
URL: |
https://ClinicalTrials.gov/show/NCT02927314
|