Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
← catalyst calendarNCT05044819 · readout in 347 d
Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →. With Jazz Pharmaceuticals Research UK Limited.
Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
154actual
Sites
26
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-07-07 | actual | When the study began enrolling |
| Primary completion | 2027-08-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-09-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Lennox Gastaut Syndrome
- Dravet Syndrome
- Tuberous Sclerosis Complex
Intervention
- Drug: Cannabidiol — also filed as Epidiolex
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Liver Fibrosis and Evaluable Fibrotic Changes as Determined and Assessed by an Independent Adjudication Committee
measured Screening, Day 365, Day 730, Day 1095, Day 1460, and Day 1825
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