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CompletedNCT00417573Updated Jan 1, 2007

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

A Phase 2 interventional study of IV Gamunex 10% in IgG Deficiency and Infections, sponsored by The Center for Rheumatic Disease, Allergy, & Immunology. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-01-01.

Sponsored by The Center for Rheumatic Disease, Allergy, & Immunology · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • IgG Deficiency
  • Infections

Keywords

  • Immunodeficiency
  • Gammaglobulin
  • IgG subclass deficiency with recurrent infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 10 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

The Center for Rheumatic Disease, Allergy, & Immunology is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with panhypogammaglobulinemia or selective IgA deficiency.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants

Interventions

  • DrugIV Gamunex 10%
06

What researchers measure

Primary outcomes

  1. Lab values ck'ed baseline and with each treatment, and 15 mo. visit

  2. Xray of Chest and sinus baseline and on 12th and last treatment

  3. Clinical assessment baseline, every treatment, and 15 mo.

Secondary outcomes

  1. Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.

07

Study locations

1 site
  • Center for Rheumatic Disease, Allergy, Immunology
    Kansas City, Missouri 64111, United States
08

References and documents

Publications

  • Abdou NI, Greenwell CA, Mehta R, Narra M, Hester JD, Halsey JF. Efficacy of intravenous gammaglobulin for immunoglobulin G subclass and/or antibody deficiency in adults. Int Arch Allergy Immunol. 2009;149(3):267-74. doi: 10.1159/000199723. Epub 2009 Feb 12. PubMed 19218820 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00417573
Lead sponsor
The Center for Rheumatic Disease, Allergy, & Immunology
Collaborators
Grifols Therapeutics LLC
First posted
Jan 1, 2007
Start date
Dec 2004
Completion
Dec 2006
Last update
Jan 1, 2007

Study contacts

Nabih I Abdou, MD, PhD
principal investigator · Center for Rheumatic Disease, Allergy, Immunology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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