Ignite Creation Date:
2024-05-05 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00781638
Status:
COMPLETED
Last Update Posted:
2012-04-03
First Post:
2008-10-28
Brief Title:
ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis
Sponsor:
Otsuka Frankfurt Research Institute GmbH
Organization:
Otsuka Frankfurt Research Institute GmbH
Study Overview
Official Title:
Open Uncontrolled Investigation to Assess the Efficacy and Safety of Adacolumn Granulocytes Monocytes Macrophage Apheresis Device in Children and Adolescents With Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2012-04
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:
Children aged up to 18 years with moderately active Ulcerative Colitis PUCAI35-64 will receive one weekly Adacolumn apheresis treatment over 5 consecutive weeks followed by up to 3 optional Adacolumn apheresis treatments over 3 consecutive weeks Primary end point is PUCAI at Week 12
The main part of the clinical investigation will be continued by a one year follow up for responders
The main part of the clinical investigation will be continued by a one year follow up for responders
Detailed Description:
The individual clinical investigation period will be 12 weeks per patient If the patient will take part in the follow up the individual clinical investigation period will be 64 weeks
Patients receive one weekly Adacolumn apheresis over 5 consecutive weeks The treating investigator may decide to add up to 3 treatments based on his judgment
Treatment details Day -07 Screening Day 00 Baseline 1st Adacolumn apheresis Day 07 2nd Adacolumn apheresis Day 14 3rd Adacolumn apheresis Day 21 4th Adacolumn apheresis Day 28 5th Adacolumn apheresis Week 12Final evaluation
Patients receive one weekly Adacolumn apheresis over 5 consecutive weeks The treating investigator may decide to add up to 3 treatments based on his judgment
Treatment details Day -07 Screening Day 00 Baseline 1st Adacolumn apheresis Day 07 2nd Adacolumn apheresis Day 14 3rd Adacolumn apheresis Day 21 4th Adacolumn apheresis Day 28 5th Adacolumn apheresis Week 12Final evaluation
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