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OpenTrials
Completed

NCT Number: NCT01166074

Retrospective Chart Review of Subcutaneous IgG Use in Infants

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

Completed

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Key information

Conditions

Primary Immune Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcutaneous IgG (SCIG)

Biological

Administered according to normal clinical practice

Other names: Vivaglobin, SCIG

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2010
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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