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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947674
Recruitment Status : Terminated (short of enrollment)
First Posted : July 28, 2009
Last Update Posted : December 6, 2012
Asahi Kasei Medical Europe GmbH
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.

July 27, 2009
July 28, 2009
December 6, 2012
May 2009
January 2012   (Final data collection date for primary outcome measure)
Clinical response [ Time Frame: at 8th week ]
Clinical response
Complete list of historical versions of study NCT00947674 on Archive Site
Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ]
Remission, Mayo scores, Mucosal healing, CRP
Not Provided
Not Provided
A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)
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
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
Device: Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
  • Experimental: Cellsorba EX
    Intervention: Device: Cellsorba EX
  • Sham Comparator: Sham treatment
    Intervention: Device: Cellsorba EX
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
January 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Israel,   Japan,   Sweden,   United Kingdom
Not Provided
Not Provided
Asahi Kasei Medical Co., Ltd.
Asahi Kasei Medical Co., Ltd.
Asahi Kasei Medical Europe GmbH
Not Provided
Asahi Kasei Medical Co., Ltd.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP