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

Asahi Kasei Medical

Status and phase

Terminated

Phase 4

Conditions

Ulcerative Colitis

Treatments

Device: Cellsorba EX

Study type

Interventional

Funder types

Industry

Identifiers

NEWS80

Details and patient eligibility

About

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

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)