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

The Center for Rheumatic Disease, Allergy, & Immunology

Status and phase: Completed; Phase 2

Conditions: Infections; IgG Deficiency

Treatments: Drug: IV Gamunex 10%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00417573

04-489

Details and patient eligibility

About

• 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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients with panhypogammaglobulinemia or selective IgA deficiency.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)