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

Group/Cohort | Intervention/treatment |
---|---|
SCIG |
Biological: Subcutaneous IgG (SCIG)
Administered according to normal clinical practice
Other Names:
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- 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
- 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 ]

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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 |
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.

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
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 |
Principal Investigator: | Melvin Berger, MD, PhD | CSL Behring |
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 |
Primary Immunodeficiency Diseases Immunologic Deficiency Syndromes Immune System Diseases Genetic Diseases, Inborn |