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.

Study Overview

• Status: Completed
• Conditions: Primary Immune Deficiency
• Intervention / Treatment: Biological: Subcutaneous IgG (SCIG)

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • Midwest Immunology Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Judes Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 2 years of age

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCIG	Biological: Subcutaneous IgG (SCIG); Administered according to normal clinical practice; Other Names: SCIG; Vivaglobin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCIG use	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	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC	1 year

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Principal Investigator: Melvin Berger, MD, PhD, CSL Behring

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (ESTIMATE): July 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2011
• Last Update Submitted That Met QC Criteria: February 10, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: Ig_6001_R_D