Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01061996
Status:
TERMINATED
Last Update Posted:
2010-02-04
First Post:
2010-02-02
Brief Title:
Basiliximab Maintenance in Ulcerative Colitis
Sponsor:
Cerimon Pharmaceuticals
Organization:
Cerimon Pharmaceuticals
Study Overview
Official Title:
An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective Safety assess the safety of basiliximab 40 mg given every 4 weeks in subjects with ulcerative colitis who completed previous basiliximab studies
Secondary Objectives evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
Secondary Objectives evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
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