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| Sponsors and Collaborators: |
The Center for Rheumatic Disease, Allergy, & Immunology Talecris Biotherapeutics |
| Information provided by: | The Center for Rheumatic Disease, Allergy, & Immunology |
| ClinicalTrials.gov Identifier: | NCT00417573 |
Purpose
| Condition | Intervention | Phase |
|
IgG Deficiency Infections |
Drug: IV Gamunex 10% |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections |
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |||||
| Center for Rheumatic Disease, Allergy, Immunology | |||||
| Kansas City, Missouri, United States, 64111 | |||||
| The Center for Rheumatic Disease, Allergy, & Immunology |
| Talecris Biotherapeutics |
| Principal Investigator: | Nabih I Abdou, MD, PhD | Center for Rheumatic Disease, Allergy, Immunology |
More Information
| Study ID Numbers: | 04-489 |
| First Received: | December 28, 2006 |
| Last Updated: | December 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00417573 |
| Health Authority: | United States: Institutional Review Board |
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