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

Infections Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00417573
Study type Interventional
Source The Center for Rheumatic Disease, Allergy, & Immunology
Contact
Status Completed
Phase Phase 2
Start date December 2004
Completion date December 2006
View Details
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