Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614387
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Safety and Efficacy of Vedolizumab in Pediatric Uclerative Colitis in Comparison With Standard Biological Therapy With Infliximab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEDI-UC
Brief Summary:
This is a multicenter double-blind randomized study to compare the safety effectiveness and immunogenicity antibodies against drug of two biological drugs administered intravenously - vedolizumab a drug not registered in pediatric patients and infliximab used as standard therapy in pediatric patients with UC aged 6-18 years
Before enrollment to the study informed consent must be obtained from the participants legal guardian and additionally from the participant aged 16 years before any procedures are performed
Before enrollment to the study informed consent must be obtained from the participants legal guardian and additionally from the participant aged 16 years before any procedures are performed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None