Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267722
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2005-12-19
Brief Title:
Visilizumab for Moderate to Severe Inflammatory Nonstricturing Nonpenetrating Crohns Disease
Sponsor:
Facet Biotech
Organization:
Facet Biotech
Study Overview
Official Title:
A Phase 2a Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory Nonstricturing Nonpenetrating Forms of Crohns Disease
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 moderate to severe inflammatory nonstricturing nonpenetrating Crohns disease The research is being conducted at up to 5 clinical research sites in the US and Europe 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 up to 17 months All study-related care and medication is provided to qualified participants at no cost this includes all visits examinations and laboratory work
Visilizumab is a humanized antibody antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances that is directed against T cells Visilizumab selectively attacks problematic T cells and in doing so it may prevent them from causing inflammation Visilizumab has also been observed to have a suppressive effect on the bodys immune system system in the body that reacts to foreign or occasionally ones own proteins
Visilizumab is a humanized antibody antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances that is directed against T cells Visilizumab selectively attacks problematic T cells and in doing so it may prevent them from causing inflammation Visilizumab has also been observed to have a suppressive effect on the bodys immune system system in the body that reacts to foreign or occasionally ones own proteins
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