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| Sponsor: | Asahi Kasei Kuraray Medical Co.,Ltd. |
|---|---|
| Collaborator: |
Asahi Kasei Medical Europe GmbH |
| Information provided by (Responsible Party): | Asahi Kasei Kuraray Medical Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT00947674 |
Purpose
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Device: Cellsorba EX |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prospective, Randomized, Double-Blind, Sham Treatment Controlled Multicenter Study to Evaluate Efficacy and Safety of Cellsorba™EX Used for Leukocytapheresis (LCAP) in Patients With Steroid-Free, Active Ulcerative Colitis |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cellsorba EX |
Device: Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
|
| Sham Comparator: Sham treatment |
Device: Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| Praha, Czech Republic | |
| Germany | |
| Hannover, Germany | |
| Rostock, Germany | |
| Israel | |
| Tel Aviv Sourasky Medical Center | |
| Tel Aviv, Israel | |
| Japan | |
| Hyogo, Japan | |
| Tokyo, Japan | |
| Sweden | |
| Gothenburg, Sweden | |
| Stockholm, Sweden | |
| United Kingdom | |
| Oxford, United Kingdom | |
| Southampton, United Kingdom | |
More Information
| Responsible Party: | Asahi Kasei Kuraray Medical Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT00947674 History of Changes |
| Other Study ID Numbers: | NEWS80 |
| Study First Received: | July 27, 2009 |
| Last Updated: | October 31, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board; Germany: Federal Institute for Drugs and Medical Devices; Israel: Ministry of Health; Japan: Institutional Review Board; United Kingdom: Research Ethics Committee; Czech Republic: Ethics Committee |
|
Cellsorba EX |
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes |