Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032305
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2002-03-14
Brief Title:
Research Study in Patients With Severe Ulcerative Colitis
Sponsor:
Facet Biotech
Organization:
Facet Biotech
Study Overview
Official Title:
A Phase I Dose-Escalation Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids
Status:
COMPLETED
Status Verified Date:
2012-03
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:
The purpose of the study is to evaluate an intravenous by injection investigational medication to treat severe ulcerative colitis refractory to steroid therapy The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old Participants in the study will have a number of visits to a research site All study-related care and medication is provided to qualified participants at no cost this includes all visits examinations and laboratory work
Detailed Description:
A Phase I dose-escalation pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy Patients who are currently receiving IV corticosteroids but whose disease has not responded after at least 5 days of this therapy will be eligible for the study
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