Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections|
- 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.
- Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2006|
*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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417573
|United States, Missouri|
|Center for Rheumatic Disease, Allergy, Immunology|
|Kansas City, Missouri, United States, 64111|
|Principal Investigator:||Nabih I Abdou, MD, PhD||Center for Rheumatic Disease, Allergy, Immunology|