NCT00417573

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: The Center for Rheumatic Disease, Allergy, & Immunology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IgG Deficiency
• Infections

Interventions

Type	Name	Description
DRUG	IV Gamunex 10%

Timeline

• Start date: 2004-12-01
• Completion: 2006-12-01
• First posted: 2007-01-01
• Last updated: 2007-01-01

Locations

1 site across 1 country: United States