Retrospective Chart Review of Subcutaneous IgG Use in Infants
Completed
Conditions studied: Primary Immune Deficiency
In brief
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
Key facts
- Study ID
- NCT01166074
- Run by
- CSL Behring
- People needed
- 27
- Starts
- 2010-05-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2011-02-11
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Hospital of Los Angeles — Los Angeles, California, United States
- University of South Florida — Tampa, Florida, United States
- Midwest Immunology Clinic — Plymouth, Minnesota, United States
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
- St. Judes Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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