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| Sponsored by: |
Talecris Biotherapeutics |
| Information provided by: | Talecris Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00220766 |
Purpose
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
| Condition | Intervention | Phase |
|
Immunologic Deficiency Syndrome Agammaglobulinemia Severe Combined Immunodeficiency Wiskott-Aldrich Syndrome Common Variable Immunodeficiency |
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Drug: Dextrose, 5% in Water |
Phase III |
| Genetics Home Reference related topics: | aceruloplasminemia adenosine deaminase deficiency hemophilia L1 syndrome thrombotic thrombocytopenic purpura X-linked severe combined immunodeficiency |
| ChemIDplus related topics: | Globulin, Immune Immunoglobulins Dextrose Caprylic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety Study |
| Official Title: | IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients |
| Enrollment: | 100 |
| Study Start Date: | August 2002 |
| Study Completion Date: | March 2004 |
| Arms | Assigned Interventions |
|
Group 1: Experimental
Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
|
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Drug: Dextrose, 5% in Water |
|
Group 2: Experimental
Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
|
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Drug: Dextrose, 5% in Water |
This is a prospective, single blind, randomized, multi-center cross-over trial in patients with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any subject with an established dose in the range of 200-399 mg/kg will be assigned to receive 400 mg/kg during the course of the study during the same dosing schedule established prior to entry into the study.
After a screening period lasting not more than four weeks, patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C, 10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min, whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema below.
Group 1:
Group 2:
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |||||
| Departments of Medicine and Microbiology | |||||
| Birmingham, Alabama, United States, 35294 | |||||
| United States, Colorado | |||||
| National Jewish Medical and Researach Center | |||||
| Denver, Colorado, United States, 80206 | |||||
| United States, District of Columbia | |||||
| International Center for Interdisciplinary Studies of Immunology | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| United States, Florida | |||||
| University of South Florida College of Medicine | |||||
| St. Petersburg, Florida, United States, 33701 | |||||
| Allergy Associates of the Palm Beaches | |||||
| North Palm Beach, Florida, United States, 33408 | |||||
| United States, Louisiana | |||||
| The Clinical Trials Center, Children's Hospital | |||||
| New Orleans, Louisiana, United States, 70118 | |||||
| United States, Nebraska | |||||
| Allergy, Asthma, and Immunology | |||||
| Omaha, Nebraska, United States, 68124 | |||||
| United States, Ohio | |||||
| University Hospitals of Cleveland | |||||
| Cleveland, Ohio, United States, 44106 | |||||
| Optimed Research, LLC | |||||
| Columbus, Ohio, United States, 43235 | |||||
| Canada, Alberta | |||||
| 3031 Hospital Drive Northwest | |||||
| Calgary, Alberta, Canada, T2N 2T8 | |||||
| Canada, British Columbia | |||||
| St. Paul's Hospital | |||||
| Vancouver, British Columbia, Canada, V6H 3K2 | |||||
| Canada, Ontario | |||||
| The Hospital for Sick Children | |||||
| Toronto, Ontario, Canada, M5G 1X8 | |||||
| Saint Michael's Hospital | |||||
| Toronto, Ontario, Canada, M4V 1R2 | |||||
| Talecris Biotherapeutics |
| Principal Investigator: | Erwin Gelfand, MD | National Jewish Medical and Research Center, Denver, CO |
More Information
| Study ID Numbers: | 100348 |
| First Received: | September 13, 2005 |
| Last Updated: | September 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00220766 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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