Retrospective Chart Review of Subcutaneous IgG Use in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Primary Immune Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SCIG

Subcutaneous IgG (SCIG)

Intervention Type BIOLOGICAL

Administered according to normal clinical practice

Interventions

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Subcutaneous IgG (SCIG)

Administered according to normal clinical practice

Intervention Type BIOLOGICAL

Other Intervention Names

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Vivaglobin SCIG

Eligibility Criteria

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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.

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No