Clinical Trial: Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary: *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.
Sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
Current 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
Original Secondary Outcome: Same as current
Information By: The Center for Rheumatic Disease, Allergy, & Immunology
Dates:
Date Received: December 28, 2006
Date Started: December 2004
Date Completion: December 2006
Last Updated: December 29, 2006
Last Verified: December 2006
