Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

doi:10.1007/s15010-012-0323-9

Review

. 2012 Dec;40(6):601-11.

doi: 10.1007/s15010-012-0323-9. Epub 2012 Sep 12.

Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

H W Schroeder Jr¹, C J Dougherty

Affiliations

PMID: 22968971
PMCID: PMC3501191
DOI: 10.1007/s15010-012-0323-9

Review

Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

H W Schroeder Jr et al. Infection. 2012 Dec.

. 2012 Dec;40(6):601-11.

doi: 10.1007/s15010-012-0323-9. Epub 2012 Sep 12.

Authors

H W Schroeder Jr¹, C J Dougherty

Affiliation

¹ Department of Medicine, Division of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, Birmingham, AL, USA.

PMID: 22968971
PMCID: PMC3501191
DOI: 10.1007/s15010-012-0323-9

Abstract

An available supply of intravenous immunoglobulin (IVIG) is essential for individuals with primary humoral immunodeficiency. A shortage in 1997 prompted the Food and Drug Administration (FDA) to revise guidelines for the licensure, production, and distribution of new IVIG products, including the standardization of United States clinical trials regarding endpoints for safety, efficacy, and pharmacokinetics. The following review is intended to present current information and results of clinical trials in patients with primary immunodeficiency treated with IVIG products currently licensed or awaiting licensure in the United States. The data presented are compiled from published clinical trials and prescribing information generated by manufacturers.

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References

1. FDA Blood Products Advisory Committee 62nd Meeting, Bethesda, Maryland, March 26, 1999. Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3504t2.pdf.
1. FDA Blood Products Advisory Committee 65th Meeting, Silver Spring, Maryland, March 17, 2000 Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3603t2a.pdf.
1. FDA/CBER. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency, 2005. http://www.fda.gov/OHRMS/DOCKETS/98fr/2005D-0438-gdl0001.pdf.
1. FDA/CBER. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency, 2008. http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecompliancere....
1. Behring EA, Kitasato S. Über das zustandekommen der Diphtherie-Immunität und der Tetanus-Immunität bei Thieren. Dtsch Med Wochenschr. 1890;16:1113–1114. doi: 10.1055/s-0029-1207589. - DOI - PubMed

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[1] FDA Blood Products Advisory Committee 62nd Meeting, Bethesda, Maryland, March 26, 1999. Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3504t2.pdf.

[2] FDA Blood Products Advisory Committee 62nd Meeting, Bethesda, Maryland, March 26, 1999. Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3504t2.pdf.

[3] FDA Blood Products Advisory Committee 65th Meeting, Silver Spring, Maryland, March 17, 2000 Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3603t2a.pdf.

[4] FDA Blood Products Advisory Committee 65th Meeting, Silver Spring, Maryland, March 17, 2000 Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3603t2a.pdf.

[5] FDA/CBER. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency, 2005. http://www.fda.gov/OHRMS/DOCKETS/98fr/2005D-0438-gdl0001.pdf.

[6] FDA/CBER. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency, 2005. http://www.fda.gov/OHRMS/DOCKETS/98fr/2005D-0438-gdl0001.pdf.

[7] FDA/CBER. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency, 2008. http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecompliancere....

[8] FDA/CBER. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency, 2008. http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecompliancere....

[9] Behring EA, Kitasato S. Über das zustandekommen der Diphtherie-Immunität und der Tetanus-Immunität bei Thieren. Dtsch Med Wochenschr. 1890;16:1113–1114. doi: 10.1055/s-0029-1207589. - DOI - PubMed

[10] Behring EA, Kitasato S. Über das zustandekommen der Diphtherie-Immunität und der Tetanus-Immunität bei Thieren. Dtsch Med Wochenschr. 1890;16:1113–1114. doi: 10.1055/s-0029-1207589. - DOI - PubMed

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Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

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Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

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