Safety and Efficacy of High-dose Leukocytapheresis Using... | NCT00888472

Studies
Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma

NCT00888472

Sponsor

Gunma University

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Bronchial Asthma

Interventions

Leukocytapheresis

Countries

Japan

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 27, 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

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

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

Description Module

Brief Summary

Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant inflammation. The investigators have already reported safety and efficacy of GCAP in refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this study, in order to improve the therapeutic effect of LCAP by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: Leukocytapheresis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leukocytapheresis	Procedure	5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of morning peak flow rate (PEFR) or evening PEFR		4 weeks after the treatment

Secondary Outcomes

Measure	Description	Time Frame
An improved score of asthma control test		4 weeks after the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.

Exclusion Criteria:

Pregnant women.
Patients with severe cardiovascular diseases.
Patients with infective diseases.
Patients with leukocytopenia or anemia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tamotsu Ishizuka, M.D.	Assistant Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department Medicine and Molecular Science, Gunma University Graduate School of Medicine		Maebashi	Gunma	371-8511	Japan

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007937	Leukapheresis

Ancestor Terms

ID	Term
D016238	Cytapheresis
D001691	Biological Therapy
D013812	Therapeutics
D001781	Blood Component Removal

Browse Leaves

Not provided

Browse Branches

Not provided