A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)

Tracking Information
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; (submitted: October 31, 2011)	Clinical response [ Time Frame: at 8th week ]
Original Primary Outcome Measures ICMJE; (submitted: July 27, 2009)	Clinical response
Change History	Complete list of historical versions of study NCT00947674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 31, 2011)	Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ]
Original Secondary Outcome Measures ICMJE; (submitted: July 27, 2009)	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
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
Study Arms	Experimental: Cellsorba EX Intervention: Device: Cellsorba EX; Sham Comparator: Sham treatment Intervention: Device: Cellsorba EX
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: December 5, 2012)	52
Original Estimated Enrollment ICMJE; (submitted: July 27, 2009)	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: Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy; Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically; Patients with Mayo score between 5 and 10; Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3; Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks Exclusion Criteria: Patients with a difficulty in peripheral vascular access; Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment); Patients with toxic megacolon; Patients with a malignant disease or its experience; Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA)); Patients with a liver or kidney disease (AST(GOT) or ALT(GPT) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as ULN, hereinafter); Patients suspected to have or having HBV or HCV or HIV or pathogenic bacteria; Patients on anticoagulant therapy or with abnormality in the blood coagulation system (PT or PTT levels which are 1.5 or more times higher than ULN; Pregnant women or patients with possible pregnancy; Breast feeding women; Patients weighing 40 kg or less; Patients with hemoglobin level of less than 6.5 mmol/L (10.5 g/dL); Patients with platelet count of less than 150 x 103/mm3, 150 x 109/L (15 x 104/mm3); Patients with white blood cell count of less than 3.5 x 109/L (3,500/mm3); Patients with hypotension (with systolic blood pressure of 80 mmHg or less)
Sex/Gender	Sexes Eligible for Study: All
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