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

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ClinicalTrials.gov Identifier: NCT00417573
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : January 1, 2007
Sponsor:
Collaborator:
Grifols Therapeutics LLC
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 involve other immunological centers in the United States to study patients with similar disease.

Condition or disease Intervention/treatment Phase
IgG Deficiency Infections Drug: IV Gamunex 10% Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Study Start Date : December 2004
Study Completion Date : December 2006
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417573


Locations
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 LLC
Investigators
Principal Investigator: Nabih I Abdou, MD, PhD Center for Rheumatic Disease, Allergy, Immunology
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00417573     History of Changes
Other Study ID Numbers: 04-489
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: January 1, 2007
Last Verified: December 2006

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
IgG Deficiency
Dysgammaglobulinemia
 Blood Protein Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases