A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)
NCT ID: NCT00947674
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
52 participants
INTERVENTIONAL
2009-05-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cellsorba EX
Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
Sham treatment
Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asahi Kasei Medical Europe GmbH
INDUSTRY
Asahi Kasei Medical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prague, , Czechia
Hanover, , Germany
Rostock, , Germany
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Hyōgo, , Japan
Tokyo, , Japan
Gothenburg, , Sweden
Stockholm, , Sweden
Oxford, , United Kingdom
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEWS80
Identifier Type: -
Identifier Source: org_study_id