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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

Page last updated: August 23, 2015

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