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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
History of Changes
  Purpose
  • 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
Infections
 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:

U.S. FDA Resources

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Inc.
Investigators
Principal Investigator: Nabih I Abdou, MD, PhD Center for Rheumatic Disease, Allergy, Immunology
  More Information

No publications provided by The Center for Rheumatic Disease, Allergy, & Immunology

Additional 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
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:
Immunodeficiency
Gammaglobulin
IgG subclass deficiency with recurrent infections

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

ClinicalTrials.gov processed this record on March 01, 2015