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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
Sponsor:
Collaborator:
Asahi Kasei Medical Europe GmbH
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.

Brief Summary:
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: Cellsorba EX Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical response [ Time Frame: at 8th week ]

Secondary Outcome Measures :
  1. Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947674


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
Sponsors and Collaborators
Asahi Kasei Medical Co., Ltd.
Asahi Kasei Medical Europe GmbH

Responsible Party: Asahi Kasei Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00947674     History of Changes
Other Study ID Numbers: NEWS80
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by Asahi Kasei Medical Co., Ltd.:
Cellsorba EX

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases