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| Sponsored by: |
Talecris Biotherapeutics |
| Information provided by: | Talecris Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00220727 |
Purpose
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.
| Condition | Intervention | Phase |
|
Purpura, Thrombocytopenic, Idiopathic |
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified |
Phase II |
| Genetics Home Reference related topics: | hemophilia thrombotic thrombocytopenic purpura |
| ChemIDplus related topics: | Globulin, Immune Immunoglobulins Caprylic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study |
| Official Title: | Randomized, Controlled, Open Study Investigating IGIV-C, 10% Given at Different Infusion Rates on Intravascular Hemolysis in Patients With Idiopathic (Immune) Thrombocytopenic Purpura (ITP) |
| Enrollment: | 8 |
| Study Start Date: | July 2003 |
| Study Completion Date: | October 2003 |
| Arms | Assigned Interventions |
|
Group 1: Experimental
Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
|
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified |
|
Group 2: Experimental
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
|
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified |
This is a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines Committee of the American Society of Hematology.
Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts < 30,000 uL or if clinically indicated, at maximum intervals of six weeks. Eligible patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at a rate of 0.08 mL/kg/min according to the following schema:
Group 1:
Group 2:
Eligibility
| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |||||
| New York Presbyterian Hospital | |||||
| New York, New York, United States, 10021-4885 | |||||
| Talecris Biotherapeutics |
| Principal Investigator: | James Bussel, MD | New York Presbyterian Hospital-Weill Medical College of Cornell University |
More Information
Study Synopsis of Results 
  |
FDA-Approved Product Labeling - Gamunex® 
  |
FDA Product Approval - Gamunex® 
  |
| Study ID Numbers: | 100422 |
| First Received: | September 13, 2005 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00220727 |
| Health Authority: | United States: Food and Drug Administration |
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