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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
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Device: Cellsorba EX
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Medical Co., Ltd.:

Primary Outcome Measures:
  • Clinical response [ Time Frame: at 8th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: May 2009
Study Completion Date: October 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Asahi Kasei Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00947674     History of Changes
Other Study ID Numbers: NEWS80
Study First Received: July 27, 2009
Last Updated: December 5, 2012
Health Authority: Sweden: Regional Ethical Review Board
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Japan: Institutional Review Board
United Kingdom: Research Ethics Committee
Czech Republic: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014