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

Asahi Kasei Medical Co., Ltd.1 site in 1 country52 target enrollmentMay 2009

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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