Retrospective Chart Review of Subcutaneous IgG Use in Infants

Completed

• Conditions: Primary Immune Deficiency
• Interventions: Biological: Subcutaneous IgG (SCIG)

• Registration Number: NCT01166074
• Lead Sponsor: CSL Behring

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 available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SCIG	Subcutaneous IgG (SCIG)	-

Primary Outcome Measures

Name	Time	Method
SCIG use	1 year	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Midwest Immunology Clinic; 🇺🇸 Plymouth, Minnesota, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

St. Judes Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States