Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382519
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-11
Brief Title:
Thalidomide Therapy for VEOIBD
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease
Status:
RECRUITING
Status Verified Date:
2024-04
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 is a single center observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease
Detailed Description:
Very early onset inflammatory bowel disease VEOIBD refers to IBD diagnosed before 6 years of age VEOIBD comprises a distinct subset of pediatric IBD characterized by stronger genetic predisposition predominant colonic involvement more extensive inflammation more severe course and peculiar response to treatments Previous studies have been demonstrated that thalidomide an oral molecule with immunomodulatory antiangiogenic and TNF-suppressing properties is an effective and safe treatment for adults and children with IBD refractory to conventional therapies This study is aimed to evaluate the efficacy and tolerance of thalidomide in VEOIBD
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