Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02797132
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Key Dates - Follows AllAPIJSON File Order
Start Date:
2016-05
Start Date Type:
ACTUAL
Primary Completion Date:
2017-09
Primary Completion Date Type:
ACTUAL
Completion Date:
2017-09
Completion Date Type:
ACTUAL
First Submit Date:
2016-05-25
First Submit QC Date:
None
Study First Post Date:
2016-06-13
Study First Post Date Type:
ESTIMATED
Results First Submit Date:
2018-09-30
Results First Submit QC Date:
None
Results First Post Date:
2018-10-30
Results First Post Date Type:
ACTUAL
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:
2018-09-30
Last Update Post Date:
2018-10-30
Last Update Post Date Type:
ACTUAL