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

Information source: The Center for Rheumatic Disease, Allergy, & Immunology
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: IgG Deficiency; Infections

Intervention: IV Gamunex 10% (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The Center for Rheumatic Disease, Allergy, & Immunology

Official(s) and/or principal investigator(s):
Nabih I Abdou, MD, PhD, Principal Investigator, Affiliation: Center for Rheumatic Disease, Allergy, Immunology

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.

Clinical Details

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

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

Primary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Starting date: December 2004
Ending date: December 2006
Last updated: December 29, 2006

Page last updated: June 20, 2008

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