Clinical trial NCT00947674: A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: Cellsorba EX
Lead sponsor: Asahi Kasei Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Asahi Kasei Medical Europe GmbH
First posted: 2009-07-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Clinical response
timeFrame: at 8th week
Secondary outcomes:
measure: Remission, Mayo scores, Mucosal healing, CRP
timeFrame: at 8th and 16th week
Other outcomes:
Locations:
city: Praha
country: Czech Republic
city: Hannover
country: Germany
city: Rostock
country: Germany
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Hyogo
country: Japan
city: Tokyo
country: Japan
city: Gothenburg
country: Sweden
city: Stockholm
country: Sweden
city: Oxford
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
References: