Retrospective Chart Review of Subcutaneous IgG Use in Infants

Primary Immune Deficiency Clinical Trial

Official title:

Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166074
• Other study ID #: Ig_6001_R_D
• Status: Completed
• Phase: N/A
• First received: July 19, 2010
• Last updated: February 10, 2011
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency

Intervention

Biological:
• Subcutaneous IgG (SCIG)
Administered according to normal clinical practice

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	St. Judes Children's Research Hospital	Memphis	Tennessee
United States	Midwest Immunology Clinic	Plymouth	Minnesota
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC		1 year	No

External Links

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