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Study 10 of 17 for search of: | "Agammaglobulinemia" |
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Sponsored by: |
Talecris Biotherapeutics |
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Information provided by: | Talecris Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00220766 |
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 |
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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 |
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 |
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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)
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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)
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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:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Erwin Gelfand, MD | National Jewish Medical and Research Center, Denver, CO |
Study ID Numbers: | 100348 |
Study 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 |
Primary Immune Deficiency IGIV Immunoglobulin G |
Agammaglobulinemia Common variable immunodeficiency Blood Protein Disorders Hemostatic Disorders Purpura, Thrombocytopenic Wiskott-Aldrich Syndrome Thrombocytopenia Hemorrhagic Disorders Genetic Diseases, X-Linked Rho(D) Immune Globulin Infant, Newborn, Diseases Wiskott Aldrich syndrome Severe combined immunodeficiency Immunoglobulins Purpura |
Metabolic Diseases Hematologic Diseases Severe Combined Immunodeficiency Blood Coagulation Disorders Blood Platelet Disorders Immunologic Deficiency Syndromes Lymphatic Diseases Thrombocytopathy Antibodies Genetic Diseases, Inborn Immunoglobulins, Intravenous Immunoglobulin G Lymphoproliferative Disorders Metabolic disorder Common Variable Immunodeficiency |
Blood Coagulation Disorders, Inherited Pathologic Processes Disease Immunologic Factors Immune System Diseases |
Syndrome Physiological Effects of Drugs DNA Repair-Deficiency Disorders Pharmacologic Actions |