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
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
- 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.
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
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.
*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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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,
- Patients with panhypogammaglobulinemia or selective IgA deficiency.
Locations and Contacts
Center for Rheumatic Disease, Allergy, Immunology, Kansas City, Missouri 64111, United States
Starting date: December 2004
Ending date: December 2006
Last updated: December 29, 2006