Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05882357
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-05-19
Brief Title:
Evaluation of ElexacaftorTezacaftorIvacaftor ELXTEZIVA in Cystic Fibrosis CF Participants 12 to Less Than 24 Months of Age
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Vertex Pharmaceuticals Incorporated
Study Overview
Official Title:
A Phase 3 Open-label Study Evaluating the Pharmacokinetics Safety and Tolerability of ElexacaftorTezacaftorIvacaftor in Cystic Fibrosis Subjects 12 to Less Than 24 Months of Age
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the pharmacokinetics PK safety tolerability pharmacodynamics PD and efficacy of ELXTEZIVA in CF subjects 12 to less than 24 months of age
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503230-49-00 | OTHER | EU CT | None |