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A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC) | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

NCT00947674•Asahi Kasei Medical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (10)

Prague, Czechia

Hanover, Germany

Rostock, Germany

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Hyōgo, Japan

Tokyo, Japan

Gothenburg, Sweden

Stockholm, Sweden

Oxford, United Kingdom

Southampton, United Kingdom

Key Dates

Start Date

May 1, 2009

Primary Completion Date

January 1, 2012

Completion Date

October 1, 2012

Last Updated

December 6, 2012

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

Cellsorba EX

DEVICE

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

View study

RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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