Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267306
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2005-12-16
Brief Title:
Ulcerative Colitis Study Study of Visilizumab in Patients With Severe Ulcerative Colitis
Sponsor:
Facet Biotech
Organization:
Facet Biotech
Study Overview
Official Title:
A Phase 12 Partially Randomized Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous 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 this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy
What is visilizumab
Visilizumab is an antibody designed to reduce inflammation Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances Visilizumab is thought to selectively affect the immune system to decrease inflammation and in doing so it may prevent damage to the intestine caused by ulcerative colitis
Who can participate in this study
The target population for this study is adults with severe ulcerative colitis that has resisted intravenous IV steroids This study is open to patients with the following characteristics
16-70 year olds
A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
Active disease despite ongoing treatment with steroids
How is this study conducted
Eligible participants will be administered visilizumab as one daily injection on two consecutive days All medication and study-related care except for the costs of in-patient hospitalization are provided to qualified participants at no cost This includes all visits examinations and laboratory work
How does one get more information
This study is currently enrolling patients at hospitals and clinics in North America and Europe For more information on the study or how to participate in it please call 1-800-772-0482 email InfoCenterpdlcom or visit wwwIBDtrialscom
What is visilizumab
Visilizumab is an antibody designed to reduce inflammation Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances Visilizumab is thought to selectively affect the immune system to decrease inflammation and in doing so it may prevent damage to the intestine caused by ulcerative colitis
Who can participate in this study
The target population for this study is adults with severe ulcerative colitis that has resisted intravenous IV steroids This study is open to patients with the following characteristics
16-70 year olds
A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
Active disease despite ongoing treatment with steroids
How is this study conducted
Eligible participants will be administered visilizumab as one daily injection on two consecutive days All medication and study-related care except for the costs of in-patient hospitalization are provided to qualified participants at no cost This includes all visits examinations and laboratory work
How does one get more information
This study is currently enrolling patients at hospitals and clinics in North America and Europe For more information on the study or how to participate in it please call 1-800-772-0482 email InfoCenterpdlcom or visit wwwIBDtrialscom
Detailed Description:
PDL BioPharma Inc was formerly known as Protein Design Labs Inc
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