Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-09 @ 10:51 AM
Study NCT ID:
NCT06431893
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-11
First Post:
2024-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥5 to ≤65 Years of Age With Classical Homocystinuria (HCU) (ENSEMBLE)
Sponsor:
Travere Therapeutics, Inc.
Organization:
Key Dates - Follows AllAPIJSON File Order
Start Date:
2024-04-30
Start Date Type:
ACTUAL
Primary Completion Date:
2027-01
Primary Completion Date Type:
ESTIMATED
Completion Date:
2027-01
Completion Date Type:
ESTIMATED
First Submit Date:
2024-05-08
First Submit QC Date:
None
Study First Post Date:
2024-05-29
Study First Post Date Type:
ACTUAL
Results First Submit Date:
None
Results First Submit QC Date:
None
Results First Post Date:
None
Results First Post Date Type:
None
Results First Post QC Date:
None
Results First Post QC Date Type:
None
Disp First Submit Date:
None
Disp First Submit QC Date:
None
Disp First Post Date:
None
Disp First Post Date Type:
None
Last Update Submit Date:
2025-04-08
Last Update Post Date:
2025-04-11
Last Update Post Date Type:
ACTUAL