Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
NCT05044819 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2026-04-22
Summary
This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
Conditions
- Lennox Gastaut Syndrome
- Dravet Syndrome
- Tuberous Sclerosis Complex
Interventions
- DRUG
-
Cannabidiol
Oral Cannabidiol solution 100 mg/mL
Sponsors & Collaborators
-
Jazz Pharmaceuticals Research UK Limited
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-07
- Primary Completion
- 2027-08-01
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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