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Retrospective Chart Review of Subcutaneous IgG Use in Infants

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ClinicalTrials.gov Identifier: NCT01166074
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
CSL Behring

Study Description
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Brief Summary:
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.

Condition or disease Intervention/treatment
Primary Immune Deficiency Biological: Subcutaneous IgG (SCIG)

Study Design
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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Groups and Cohorts
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Group/Cohort Intervention/treatment
SCIG Biological: Subcutaneous IgG (SCIG)
Administered according to normal clinical practice
Other Names:
  • Vivaglobin
  • SCIG


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under 2 years of age
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166074


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Minnesota
Midwest Immunology Clinic
Plymouth, Minnesota, United States, 55446
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Tennessee
St. Judes Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
CSL Behring
Investigators
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Principal Investigator: Melvin Berger, MD, PhD CSL Behring
More Information
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Responsible Party: Global Head Clinical Research & Development, CSL Behring
ClinicalTrials.gov Identifier: NCT01166074    
Other Study ID Numbers: Ig_6001_R_D
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn