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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00162006 |
The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.
Condition | Intervention | Phase |
---|---|---|
Idiopathic Thrombocytopenic Purpura |
Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
Institute of Haematology and Blood Transfusion | |
Prague, Czech Republic, 128 00 | |
University Hospital Olomouc | |
Olomouc, Czech Republic, 775 20 | |
University Hospital Brno | |
Brno, Czech Republic, 625 00 | |
University Hospital Hradec Králové | |
Hradec Králové, Czech Republic, 500 05 | |
Germany | |
Julius-Liebig Universität Giessen, Center for Internal Medicine, Department of Hematology/Oncology | |
Giessen, Germany, 35385 | |
Martin-Luther University Halle-Wittenberg, Klinik u. Poliklinik f. Innere Medizin IV, Hematology and Oncology | |
Halle/Saale, Germany, 06112 | |
Hungary | |
University of Szeged, Second Clinic of Internal Medicine | |
Szeged, Hungary, 6720 | |
Markusovszky Hospital, Department of Hematology | |
Szombathely, Hungary, 9700 | |
University of Debrecen, Second Clinic of Internal Medicine | |
Debrecen, Hungary, 4012 | |
University of Szeged, Second Clinic of Internal Medicine | |
Szeged, Hungary, 6701 | |
Petz Aladár Teaching Hospital Györ | |
Györ, Hungary, 9002 | |
Poland | |
Medical University of Lodz, Hematology Clinic | |
Lodz, Poland, 90-419 |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
Study ID Numbers: | 160002 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00162006 History of Changes |
Health Authority: | Czech Republic: State Institute for Drug Control; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; Poland: Ministry of Health |
Chronic idiopathic thrombocytopenic purpura |
Purpura Autoimmune Diseases Immunologic Factors Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic Signs and Symptoms |
Thrombocytopathy Antibodies Thrombocytopenia Hemorrhagic Disorders Immunoglobulins, Intravenous Thrombocytopenic Purpura, Autoimmune Purpura, Thrombocytopenic, Idiopathic Rho(D) Immune Globulin Immunoglobulins |
Purpura Skin Manifestations Autoimmune Diseases Immunologic Factors Immune System Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Physiological Effects of Drugs Pharmacologic Actions |
Purpura, Thrombocytopenic Signs and Symptoms Antibodies Thrombocytopenia Hemorrhagic Disorders Immunoglobulins, Intravenous Purpura, Thrombocytopenic, Idiopathic Rho(D) Immune Globulin Immunoglobulins |