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

This study has been completed.
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier:
NCT00417573
First received: December 28, 2006
Last updated: December 29, 2006
Last verified: December 2006

December 28, 2006
December 29, 2006
December 2004
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00417573 on ClinicalTrials.gov Archive Site
Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
Same as current
Not Provided
Not Provided
 
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
  • 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.

*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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • IgG Deficiency
  • Infections
Drug: IV Gamunex 10%
Not Provided
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. Epub 2009 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00417573
04-489
Not Provided
Not Provided
The Center for Rheumatic Disease, Allergy, & Immunology
Grifols Therapeutics Inc.
Principal Investigator: Nabih I Abdou, MD, PhD Center for Rheumatic Disease, Allergy, Immunology
The Center for Rheumatic Disease, Allergy, & Immunology
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP