Retrospective Chart Review of Subcutaneous IgG Use in Infants

This study has been completed.
Sponsor:
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT01166074
First received: July 19, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Primary Immune Deficiency
Biological: Subcutaneous IgG (SCIG)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • SCIG use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SCIG Biological: Subcutaneous IgG (SCIG)
Administered according to normal clinical practice
Other Names:
  • Vivaglobin
  • SCIG

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166074

Locations
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
Principal Investigator: Melvin Berger, MD, PhD CSL Behring
  More Information

Additional Information:
No publications provided

Responsible Party: Global Head Clinical Research & Development, CSL Behring
ClinicalTrials.gov Identifier: NCT01166074     History of Changes
Other Study ID Numbers: Ig_6001_R_D
Study First Received: July 19, 2010
Last Updated: February 10, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 26, 2014