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Retrospective Chart Review of Subcutaneous IgG Use in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01166074
First Posted: July 20, 2010
Last Update Posted: February 11, 2011
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.
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
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
SCIG
Intervention: Biological: Subcutaneous IgG (SCIG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01166074
Ig_6001_R_D
No
Not Provided
Not Provided
Global Head Clinical Research & Development, CSL Behring
CSL Behring
Not Provided
Principal Investigator: Melvin Berger, MD, PhD CSL Behring
CSL Behring
February 2011