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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2009

Last Updated Date

December 5, 2012

Start Date ^ICMJE

May 2009

Primary Completion Date

January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical response [ Time Frame: at 8th week ]

Original Primary Outcome Measures ^ICMJE

Clinical response

Change History

Complete list of historical versions of study NCT00947674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Remission, Mayo scores, Mucosal healing, CRP [ Time Frame: at 8th and 16th week ]

Original Secondary Outcome Measures ^ICMJE

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

Enrollment ^ICMJE

Completion Date

October 2012

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

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

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

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