Retrospective Chart Review of Subcutaneous IgG Use in Inf... | NCT01166074

Studies
Retrospective Chart Review of Subcutaneous IgG Use in Infants

NCT01166074

Sponsor

CSL Behring

Status

Completed

Last Update Posted

Feb 11, 2011Estimated

Enrollment

27Actual

Phase

Not provided

Conditions

Primary Immune Deficiency

Interventions

Subcutaneous IgG (SCIG)

Countries

United States

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 2011

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

May 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jul 19, 2010

First Submission Date that Met QC Criteria

Jul 19, 2010

First Posted Date

Jul 20, 2010Estimated

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 10, 2011

Last Update Posted Date

Feb 11, 2011Estimated

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

This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCIG			Biological: Subcutaneous IgG (SCIG)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous IgG (SCIG)	Biological	Administered according to normal clinical practice	SCIG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCIG use	To describe the use of SCIG in infants below the age of two years in major academic medical centers and immunologists' practices in the US	1 year

Secondary Outcomes

Measure	Description	Time Frame
Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants who received more than one dose of IgG by the subcutaneous route before the age of two years.
Consent of parent/guardian if required by institution/IRB.

Exclusion Criteria:

Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy.
Concomitant treatment with plasma, other blood products or IGIV while on SCIG.
Lack of consent by parent/guardian (if required by Institution/IRB).
Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

Children under 2 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melvin Berger, MD, PhD	CSL Behring	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Los Angeles		Los Angeles	California	90027	United States
University of South Florida

Condition Browse Module

MeSH Terms

ID	Term
D000081207	Primary Immunodeficiency Diseases

Ancestor Terms

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C510539	Vivaglobin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided