Status:

COMPLETED

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

Lead Sponsor:

The Center for Rheumatic Disease, Allergy, & Immunology

Collaborating Sponsors:

Grifols Therapeutics LLC

Conditions:

IgG Deficiency

Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 i...

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...

Eligibility Criteria

Inclusion

  • 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, and/or skin.

Exclusion

  • Patients with panhypogammaglobulinemia or selective IgA deficiency.

Key Trial Info

Start Date :

December 1 2004

Trial Type :

INTERVENTIONAL

End Date :

December 1 2006

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00417573

Start Date

December 1 2004

End Date

December 1 2006

Last Update

January 1 2007

Active Locations (1)

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Center for Rheumatic Disease, Allergy, Immunology

Kansas City, Missouri, United States, 64111