Retrospective Chart Review of Subcutaneous IgG Use in Infants

CSL Behring

Status: Completed

Conditions: Primary Immune Deficiency

Treatments: Biological: Subcutaneous IgG (SCIG)

Study type: Observational

Funder types: Industry

Identifiers

NCT01166074

Ig_6001_R_D

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

27 participants in 1 patient group

SCIG

Treatment:

Biological: Subcutaneous IgG (SCIG)