Status:
COMPLETED
Retrospective Chart Review of Subcutaneous IgG Use in Infants
Lead Sponsor:
CSL Behring
Conditions:
Primary Immune Deficiency
Eligibility:
All Genders
Up to 2 years
Brief Summary
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01166074
Start Date
May 1 2010
End Date
December 1 2010
Last Update
February 11 2011
Active Locations (5)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of South Florida
Tampa, Florida, United States, 33612
3
Midwest Immunology Clinic
Plymouth, Minnesota, United States, 55446
4
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106