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

Tracking Information

First Received Date ^ICMJE

December 28, 2006

Last Updated Date

December 29, 2006

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00417573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

IgG Deficiency
Infections

Intervention ^ICMJE

Drug: IV Gamunex 10%

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00417573

Responsible Party

Study ID Numbers ^ICMJE

04-489

Study Sponsor ^ICMJE

The Center for Rheumatic Disease, Allergy, & Immunology

Collaborators ^ICMJE

Talecris Biotherapeutics

Investigators ^ICMJE

Principal Investigator:

Nabih I Abdou, MD, PhD

Center for Rheumatic Disease, Allergy, Immunology

Information Provided By

The Center for Rheumatic Disease, Allergy, & Immunology

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP