Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366925
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2006-08-21
Brief Title:
CESA 510 Investigation to Compare the Efficacy and Safety of the Adacolumn Apheresis Device in Patients With Active Ulcerative Colitis
Sponsor:
Otsuka Frankfurt Research Institute GmbH
Organization:
Otsuka Frankfurt Research Institute GmbH
Study Overview
Official Title:
Randomized Controlled Multicenter Investigation to Compare the Efficacy and Safety of Adacolumn Granulocytes MonocytesMacrophage Apheresis Device 5 Versus 10 Treatments in Patients With Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2009-04
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:
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn treatments over 5 weeks to 10 treatments two Adacolumn apheresis treatments during the first 2 weeks followed by 6 weeks with one Adacolumn apheresis treatment in patients with active ulcerative colitis
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