Retrospective Chart Review of Subcutaneous IgG Use in Infants
Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
1 other identifier
observational
27
1 country
5
Brief Summary
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2010
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 11, 2011
February 1, 2011
7 months
July 19, 2010
February 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC
1 year
Study Arms (1)
SCIG
Interventions
Administered according to normal clinical practice
Eligibility Criteria
Children under 2 years of age
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melvin Berger, MD, PhD
CSL Behring
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 20, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 11, 2011
Record last verified: 2011-02