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Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
This study has been completed.
Sponsor:
The Center for Rheumatic Disease, Allergy, & Immunology
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
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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 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 |
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 |
*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 (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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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
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
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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017