Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00702611
Status:
TERMINATED
Last Update Posted:
2015-09-07
First Post:
2008-06-19
Brief Title:
Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis
Sponsor:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Organization:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study Overview
Official Title:
An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone Plus Adacolumn GMA Apheresis vs Prednisone Alone in the Treatment of Patients With Mild or Moderately Active Steroid Dependent Ulcerative Colitis
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATICCA
Brief Summary:
The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients
Detailed Description:
This is a multicenter randomized controlled trial which will compare the efficacy and safety of Adacolumn GMA apheresis plus oral steroids vs steroids alone in a strictly selected population of moderate to severe active steroid dependant Ulcerative Colitis patients
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