Show 30 earlier versions
2025-03-26
minor
Study Status, Contacts/Locations v30
2025-02-20
minor
3 amendments v27-v29
3 re-verifications since 2024-12-11, no change to tracked fields
2024-10-11
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v26
Collaborators+40 characters
Jazz Pharmaceuticals Research UK Limited
2024-09-27
minor
4 amendments v22-v25
4 re-verifications since 2024-06-05, no change to tracked fields
2024-05-29
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 150→confirmed 154
Study sites35→26
Secondary endpoints8 entries, revised
Number of Participants with Severe Treatment-emergent Adverse Events (TEAEs)
2024-03-07
minor
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 35 sites
2024-02-27
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 35 sites
2024-01-26
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 35 sites
2024-01-11
minor
Study Status, Contacts/Locations v17
Study sitesdetails revised at 2 of 35 sites
2023-11-30
minor
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 35 sites
2023-11-17
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 35 sites
2023-10-30
minor
Study Status, Contacts/Locations v14
Study sitesdetails revised at 3 of 35 sites
2023-08-11
minor
Study Status, Contacts/Locations v13
2023-07-18
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v12
Eligibility criteria+201 characters
Inclusion Criteria:
Participant is within the approved age range as per labeling recommendations.
Participants aged 1 to 3 years who are in the FibroScan subset will not undergo FibroScan assessments until they reach 4 years of age.
Participant is either on existing Epidiolex therapy for trea [...] ticipant has diseases or disorders which are associated with known severe liver fibrosis with a FibroScan score of ≥ 6.5 Kilopascals (where FibroScan results are available).
Positive serology panel (including hepatitis B surface ant [...] ice implanted that is contraindicated for use with FibroScan (only applicab [...] [...]
Secondary endpoints8 entries, revised
Change From Baseline in FibroScan Scoring (FibroScan subset only)
2023-05-09
minor
2 amendments v10-v11
2 re-verifications since 2023-04-04, no change to tracked fields
2023-03-10
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 31 sites
2023-02-13
minor
Study Status v8
Re-verified, no change to tracked fields
2023-01-17
minor
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 31 sites
2022-12-19
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 31 sites
2022-11-11
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 3 of 31 sites
2022-10-12
minor
Study Status v4
Re-verified, no change to tracked fields
2022-09-21
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 31 sites
2022-08-04
minor
Study Status, Contacts/Locations v2
Study sitesdetails revised at 1 of 31 sites
2022-06-30
minor
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v1
Study sites29→31
Lead sponsorGW Research Ltd→Jazz Pharmaceuticals