Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

This study has been completed.

First Received: December 28, 2006 Last Updated: December 29, 2006 History of Changes

Sponsor:	The Center for Rheumatic Disease, Allergy, & Immunology
Collaborator:	Talecris Biotherapeutics
Information provided by:	The Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier:	NCT00417573

Purpose

This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency.
Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.

Condition	Intervention	Phase
IgG Deficiency Infections	Drug: IV Gamunex 10%	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia X-linked hyper IgM syndrome

U.S. FDA Resources

Further study details as provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Primary Outcome Measures:

Lab values ck'ed baseline and with each treatment, and 15 mo. visit
Xray of Chest and sinus baseline and on 12th and last treatment
Clinical assessment baseline, every treatment, and 15 mo.

Secondary Outcome Measures:

Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.

Estimated Enrollment:	10
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2006

Detailed Description:

10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.

Exclusion Criteria:

Patients with panhypogammaglobulinemia or selective IgA deficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417573

Locations

United States, Missouri
Center for Rheumatic Disease, Allergy, Immunology
Kansas City, Missouri, United States, 64111

Sponsors and Collaborators

The Center for Rheumatic Disease, Allergy, & Immunology

Talecris Biotherapeutics

Investigators

Principal Investigator:

Nabih I Abdou, MD, PhD

Center for Rheumatic Disease, Allergy, Immunology

More Information

No publications provided by The Center for Rheumatic Disease, Allergy, & Immunology

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Abdou NI, Greenwell CA, Mehta R, Narra M, Hester JD, Halsey JF. Efficacy of intravenous gammaglobulin for immunoglobulin G subclass and/or antibody deficiency in adults. Int Arch Allergy Immunol. 2009;149(3):267-74. Epub 2009 Feb 12.

Study ID Numbers:	04-489
Study First Received:	December 28, 2006
Last Updated:	December 29, 2006
ClinicalTrials.gov Identifier:	NCT00417573 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Immunodeficiency
Gammaglobulin
IgG subclass deficiency with recurrent infections

Additional relevant MeSH terms:

Communicable Diseases
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders

IgG Deficiency
Dysgammaglobulinemia
Infection
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009