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

This study has been completed.
Grifols Therapeutics Inc.
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology Identifier:
First received: December 28, 2006
Last updated: December 29, 2006
Last verified: December 2006
  • 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.

Condition Intervention Phase
IgG Deficiency
Drug: IV Gamunex 10%
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

Resource links provided by NLM:

Further study details as provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Primary Outcome Measures:
  • Lab values ck'ed baseline and with each treatment, and 15 mo. visit
  • Xray of Chest and sinus baseline and on 12th and last treatment
  • Clinical assessment baseline, every treatment, and 15 mo.

Secondary Outcome Measures:
  • Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.

Estimated Enrollment: 10
Study Start Date: December 2004
Estimated Study Completion Date: December 2006
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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:

  • Patients with panhypogammaglobulinemia or selective IgA deficiency.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00417573

United States, Missouri
Center for Rheumatic Disease, Allergy, Immunology
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
The Center for Rheumatic Disease, Allergy, & Immunology
Grifols Therapeutics Inc.
Principal Investigator: Nabih I Abdou, MD, PhD Center for Rheumatic Disease, Allergy, Immunology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00417573     History of Changes
Other Study ID Numbers: 04-489 
Study First Received: December 28, 2006
Last Updated: December 29, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:
IgG subclass deficiency with recurrent infections

Additional relevant MeSH terms:
Communicable Diseases
IgG Deficiency
Blood Protein Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016