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

December 5, 2012 updated by: Asahi Kasei Medical Co., Ltd.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Praha, Czech Republic
  • Germany
      • Hannover, Germany
      • Rostock, Germany
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Hyogo, Japan
      • Tokyo, Japan
  • Sweden
      • Gothenburg, Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Oxford, United Kingdom
      • Southampton, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: Cellsorba EX
Device: Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response
Time Frame: at 8th week
at 8th week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Kasei Medical Co., Ltd.

Collaborators

Asahi Kasei Medical Europe GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEWS80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on Cellsorba EX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe