CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis
NCT00366925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2009-04-28
Summary
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.
Conditions
Interventions
- DEVICE
-
Adacolumn®
Sponsors & Collaborators
-
Otsuka Frankfurt Research Institute GmbH
lead INDUSTRY
Principal Investigators
-
Axel Dignass, Prof. Dr. med. · Markus-Krankenhaus, Frankfurt am Main
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2008-02-29
- Completion
- 2008-07-31
Countries
- Germany
Study Locations
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