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Sponsored by: |
Otsuka Frankfurt Research Institute GmbH |
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Information provided by: | Otsuka Frankfurt Research Institute GmbH |
ClinicalTrials.gov Identifier: | NCT00781638 |
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.
Condition | Intervention |
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Ulcerative Colitis |
Device: Adacolumn® |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Receiving or having received one or more of the following medicinal products before screening:
Exclusion Criteria:
Infection:
Responsible Party: | Otsuka Frankfurt Research Institute ( Otsuka Frankfurt Research Institute ) |
Study ID Numbers: | Ada-UC-08-101 |
Study First Received: | October 28, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00781638 |
Health Authority: | Finland: National Agency for Medicines; Finland: Ethics Committee |
Pediatric UC, Adacolumn apheresis |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |