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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- Patients with panhypogammaglobulinemia or selective IgA deficiency.

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
United States, Missouri | |
Center for Rheumatic Disease, Allergy, Immunology | |
Kansas City, Missouri, United States, 64111 |
Principal Investigator: | Nabih I Abdou, MD, PhD | Center for Rheumatic Disease, Allergy, Immunology |
ClinicalTrials.gov Identifier: | NCT00417573 |
Other Study ID Numbers: |
04-489 |
First Posted: | January 1, 2007 Key Record Dates |
Last Update Posted: | January 1, 2007 |
Last Verified: | December 2006 |
Immunodeficiency Gammaglobulin IgG subclass deficiency with recurrent infections |
Infections Communicable Diseases IgG Deficiency Reinfection Disease Attributes Pathologic Processes Recurrence Dysgammaglobulinemia |
Blood Protein Disorders Hematologic Diseases Immunologic Deficiency Syndromes Immune System Diseases Immunoglobulins, Intravenous Immunologic Factors Physiological Effects of Drugs |