Retrospective Chart Review of Subcutaneous IgG Use in Infants
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Immune Deficiency
Intervention: Subcutaneous IgG (SCIG) (Biological)
Phase: N/A
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s):
Melvin Berger, MD, PhD, Principal Investigator, Affiliation: CSL Behring
Summary
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants
less than two years old.
Clinical Details
Official title: Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: SCIG use
Secondary outcome: Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC
Eligibility
Minimum age: N/A.
Maximum age: 2 Years.
Gender(s): Both.
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.
Locations and Contacts
Children's Hospital of Los Angeles, Los Angeles, California 90027, United States
University of South Florida, Tampa, Florida 33612, United States
Midwest Immunology Clinic, Plymouth, Minnesota 55446, United States
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States
St. Judes Children's Research Hospital, Memphis, Tennessee 38105, United States
Additional Information
Click here to request more information about this study
Starting date: May 2010
Last updated: February 10, 2011
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