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| Sponsor: | Asahi Kasei Kuraray Medical Co.,Ltd. |
|---|---|
| Collaborator: |
Asahi Kasei Medical Europe GmbH |
| Information provided by: | 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Arms | Assigned Interventions |
|---|---|
| Cellsorba EX: Experimental | Device: Cellsorba EX |
| Sham treatment: Sham Comparator | Device: Cellsorba EX |
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| Contact: Hiroshi Shibata | 81-3-3296-3736 | shibata.hd@om.asahi-kasei.co.jp |
| Contact: Kaoru Furuya | 49-696-637-1502 | furuya.kb@om.asahi-kasei.co.jp |
| Germany | |
| Recruiting | |
| Hannover, Germany | |
| Israel | |
| Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel | |
| Japan | |
| Not yet recruiting | |
| Tokyo, Japan | |
| Japan, Hyogo | |
| Not yet recruiting | |
| Nishinomiya, Hyogo, Japan | |
| Sweden | |
| Recruiting | |
| Stockholm, Sweden | |
More Information
| Study ID Numbers: | NEWS80 |
| Study First Received: | July 27, 2009 |
| Last Updated: | January 20, 2010 |
| ClinicalTrials.gov Identifier: | NCT00947674 History of Changes |
| Health Authority: | Sweden: Regional Ethical Review Board; Germany: Federal Institute for Drugs and Medical Devices; Israel: Ministry of Health; Japan: Institutional Review Board |
|
Cellsorba EX |
|
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |