Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599465
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2020-10-21
Brief Title:
A Study to Assess the Effect of ELXTEZIVA on Glucose Tolerance in Participants With Cystic Fibrosis CF
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Vertex Pharmaceuticals Incorporated
Study Overview
Official Title:
A Phase 3b Open-label Study to Assess the Effect of Elexacaftor ELXTezacaftor TEZIvacaftor IVA on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism
Status:
COMPLETED
Status Verified Date:
2023-07
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 was evaluate the effect of elexacaftor ELXtezacaftor TEZivacaftor IVA on glucose tolerance in CF participants 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation FMF genotypes with abnormal glucose metabolism
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003170-44 | EUDRACT_NUMBER | None | None |