NCT00781638

ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Otsuka Frankfurt Research Institute GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) 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.

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 12:Final evaluation

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Adacolumn®	The medical device Adacolumn® (CE-Mark Certificate G1 07 01 366 76013) is an adsorptive type extracorporeal apheresis column. It has been shown to effectively improve clinical and endoscopic signs and symptoms in UC in adults by removing granulocytes and monocytes and by changing the Cytokine production.

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-10-29
• Last updated: 2012-04-03