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ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

NCT00781638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-04-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Otsuka Frankfurt Research Institute GmbH

    lead INDUSTRY

Principal Investigators

  • Tarja Ruuska, MD, PhD · Tampere University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781638 on ClinicalTrials.gov