IVIG Treatment for Asthmatic Patients With IgG Subclass D... | NCT01992328

Studies
IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

NCT01992328

Sponsor

Ajou University School of Medicine

Status

Unknown status

Last Update Posted

May 2, 2016Estimated

Enrollment

30Estimated

Phase

Phase 3

Conditions

Asthma

Interventions

Immune Globulin

Countries

Not provided

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Nov 19, 2013

First Posted Date

Nov 25, 2013Estimated

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

Apr 28, 2016

Last Update Posted Date

May 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hae-Sim Park, Professor, Department of medicine, Ajou University School of Medicine, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate.

Detailed Description

Patients Registration

•It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

Procedure

•six months once a month intravenous immunoglobulin (400mg/kg/4weeks)

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immune Globulin	Experimental	Immunoglobulin G Deficiency Associated with persistent asthma subtypes	Drug: Immune Globulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immune Globulin	Drug	6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)	Immune Globulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infection rate	6 months after treatment compared to before treatment 6 months	6months

Secondary Outcomes

Measure	Description	Time Frame
lung funtion	- Lung function (FEV1) compared	6 months
steroid	- Systemic steroid dose and the number of uses	6 months af

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient from over 16 years to under 75 years
Patients diagnosed with asthma over six months ago
immunoglobulin G subtypes who were diagnosed with immune deficiency
more than 2 years Upper and lower respiratory tract infections

, and asthma exacerbations in this regard.
① calculated creatinine clearance ≧ 50ml/min
- ALT and AST \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
hae-sim park	Department of medicine, Ajou University School of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D017099	IgG Deficiency

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
D007136	Immunoglobulins

Ancestor Terms

ID	Term
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided