Retrospective Chart Review of Subcutaneous IgG Use in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166074
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : February 11, 2011
Information provided by:
CSL Behring

July 19, 2010
July 20, 2010
February 11, 2011
May 2010
December 2010   (Final data collection date for primary outcome measure)
SCIG use [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01166074 on Archive Site
Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC [ Time Frame: 1 year ]
Same as current
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Retrospective Chart Review of Subcutaneous IgG Use in Infants
Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
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Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
Children under 2 years of age
Primary Immune Deficiency
Biological: Subcutaneous IgG (SCIG)
Administered according to normal clinical practice
Other Names:
  • Vivaglobin
  • SCIG
Intervention: Biological: Subcutaneous IgG (SCIG)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 2 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Global Head Clinical Research & Development, CSL Behring
CSL Behring
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Principal Investigator: Melvin Berger, MD, PhD CSL Behring
CSL Behring
February 2011