A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)
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ClinicalTrials.gov Identifier: NCT00947674 |
Recruitment Status
:
Terminated
(short of enrollment)
First Posted
: July 28, 2009
Last Update Posted
: December 6, 2012
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Sponsor:
Asahi Kasei Medical Co., Ltd.
Collaborator:
Asahi Kasei Medical Europe GmbH
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.
Tracking Information | |||
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First Submitted Date ICMJE | July 27, 2009 | ||
First Posted Date ICMJE | July 28, 2009 | ||
Last Update Posted Date | December 6, 2012 | ||
Study Start Date ICMJE | May 2009 | ||
Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Clinical response [ Time Frame: at 8th week ] | ||
Original Primary Outcome Measures ICMJE |
Clinical response | ||
Change History | Complete list of historical versions of study NCT00947674 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ] | ||
Original Secondary Outcome Measures ICMJE |
Remission, Mayo scores, Mucosal healing, CRP | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC) | ||
Official Title ICMJE | 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 | ||
Brief Summary | This is a prospective, randomized, double-blind, sham treatment controlled multicenter study. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Ulcerative Colitis | ||
Intervention ICMJE | Device: Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
52 | ||
Original Estimated Enrollment ICMJE |
80 | ||
Actual Study Completion Date | October 2012 | ||
Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Czech Republic, Germany, Israel, Japan, Sweden, United Kingdom | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00947674 | ||
Other Study ID Numbers ICMJE | NEWS80 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Asahi Kasei Medical Co., Ltd. | ||
Study Sponsor ICMJE | Asahi Kasei Medical Co., Ltd. | ||
Collaborators ICMJE | Asahi Kasei Medical Europe GmbH | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Asahi Kasei Medical Co., Ltd. | ||
Verification Date | December 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |