IgG Deficiency, Infections
Conditions
Keywords
Immunodeficiency, Gammaglobulin, IgG subclass deficiency with 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.
Interventions
DRUGIV Gamunex 10%
Sponsors
Grifols Therapeutics LLC
The Center for Rheumatic Disease, Allergy, & Immunology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist. | — |
Countries
United States
Outcome results
None listed