Status:
TERMINATED
A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)
Lead Sponsor:
Asahi Kasei Medical Co., Ltd.
Collaborating Sponsors:
Asahi Kasei Medical Europe GmbH
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00947674
Start Date
May 1 2009
End Date
October 1 2012
Last Update
December 6 2012
Active Locations (10)
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1
Prague, Czechia
2
Hanover, Germany
3
Rostock, Germany
4
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel