This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Oral Cannabidiol solution 100 mg/mL
Clinical Trial Site
Little Rock, Arkansas, United States
Number of Participants With Liver Fibrosis and Evaluable Fibrotic Changes as Determined and Assessed by an Independent Adjudication Committee
Time frame: Screening, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Change From Baseline in Aspartate Aminotransferase (AST) to Platelet Ratio Index
Time frame: Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Change from Baseline in the Enhanced Liver Fibrosis Score
Time frame: Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Change From Baseline in Fibrosis-4
Time frame: Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Change From Baseline in FibroScan Scoring (FibroScan subset only)
Time frame: Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Number of Participants With Potential Drug-Induced Liver Injury (DILI)
Time frame: Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Number of Participants with Severe Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Number of Participants With Clinically Significant Clinical Laboratory Findings
Time frame: Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
Number of Participants With Clinically Significant Physical Examinations
Time frame: Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
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Clinical Trial Site
Downey, California, United States
Clinical Trial Site
Long Beach, California, United States
Clinical Trial Site
Sacramento, California, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
Tampa, Florida, United States
Clinical Trial Site
Augusta, Georgia, United States
Clinical Trial Site
Wichita, Kansas, United States
...and 16 more locations