A Study of Leukocytapheresis (LCAP) in Patients With Ulce... | NCT00947674

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

NCT00947674

Sponsor

Asahi Kasei Medical Co., Ltd.

Status

Terminated

Last Update Posted

Dec 6, 2012Estimated

Enrollment

52Actual

Phase

Phase 4

Conditions

Ulcerative Colitis

Interventions

Cellsorba EX

Countries

Czechia
Germany
Israel
Japan
Sweden
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

short of enrollment

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jul 27, 2009

First Submission Date that Met QC Criteria

Jul 27, 2009

First Posted Date

Jul 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2012

Last Update Posted Date

Dec 6, 2012Estimated

Name	Class
Asahi Kasei Medical Europe GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
Cellsorba EX	Experimental		Device: Cellsorba EX
Sham treatment	Sham Comparator		Device: Cellsorba EX

Name	Type	Description	Arm Group Labels	Other Names
Cellsorba EX	Device	conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times	Cellsorba EX Sham treatment

Measure	Description	Time Frame
Clinical response		at 8th week

Measure	Description	Time Frame
Remission, Mayo scores, Mucosal healing, CRP		at 8th and 16th week

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Prague			Czechia

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases