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

This study has been terminated.
(short of enrollment)
Sponsor:
Collaborator:
Asahi Kasei Medical Europe GmbH
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00947674
First received: July 27, 2009
Last updated: December 5, 2012
Last verified: December 2012

July 27, 2009
December 5, 2012
May 2009
January 2012   (final data collection date for primary outcome measure)
Clinical response [ Time Frame: at 8th week ] [ Designated as safety issue: No ]
Clinical response
Complete list of historical versions of study NCT00947674 on ClinicalTrials.gov Archive Site
Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
52
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Israel,   Japan,   Sweden,   United Kingdom
 
NCT00947674
NEWS80
No
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