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

Study Overview
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Brief Summary
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This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: Cellsorba EX


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cellsorba EX<br> | Device: Cellsorba EX<br>* conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times<br>|
| Sham Comparator: Sham treatment<br> | Device: Cellsorba EX<br>* conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  | at 8th week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellsorba EX