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

Phase 4

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Device: Cellsorba EX

• Registration Number: NCT00947674
• Lead Sponsor: Asahi Kasei Medical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Primary Completion: 2012-01
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cellsorba EX	Cellsorba EX	-
Sham treatment	Cellsorba EX	-

Primary Outcome Measures

Name	Time	Method
Clinical response	at 8th week

Secondary Outcome Measures

Name	Time	Method
Remission, Mayo scores, Mucosal healing, CRP	at 8th and 16th week

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel