Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	The Center for Rheumatic Disease, Allergy, & Immunology 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

Genetics Home Reference related topics:

aceruloplasminemia

U.S. FDA Resources

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

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

Study ID Numbers:	04-489
First Received:	December 28, 2006
Last Updated:	December 29, 2006
ClinicalTrials.gov Identifier:	NCT00417573
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

Study placed in the following topic categories:

Gamma-Globulins

Immunoglobulins, Intravenous

Hematologic Diseases

IgG Deficiency

Rho(D) Immune Globulin

Recurrence

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases

Immune System Diseases

Blood Protein Disorders

Dysgammaglobulinemia

Infection

ClinicalTrials.gov processed this record on September 05, 2008