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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00947674
• Other study ID #: NEWS80
• Status: Terminated
• Phase: Phase 4
• First received: July 27, 2009
• Last updated: December 5, 2012
• Start date: May 2009
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Asahi Kasei Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardGermany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthJapan: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeCzech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: October 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Cellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Asahi Kasei Medical Co., Ltd.	Asahi Kasei Medical Europe GmbH

Countries where clinical trial is conducted

Czech Republic,  Germany,  Israel,  Japan,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response		at 8th week	No
Secondary	Remission, Mayo scores, Mucosal healing, CRP		at 8th and 16th week	Yes