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

The Center for Rheumatic Disease, Allergy, & Immunology10 enrolled

Overview

* 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.

\*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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgG Deficiency Infections

Interventions

IV Gamunex 10%DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Center for Rheumatic Disease, Allergy, Immunology

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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