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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161993 |
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
Condition | Intervention | Phase |
---|---|---|
Hypogammaglobulinemia Agammaglobulinemia Primary Immunodeficiency (PID) |
Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution Drug: Gammagard S/D (Solvent/Detergent) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Subjects will be eligible for study entry if they:
Exclusion Criteria:
Subjects will not be eligible for study entry if they:
Finland | |
Turku University Central Hospital | |
Turku, Finland, 205 20 | |
Tampere University Hospital | |
Tampere, Finland, 33 521 | |
Sweden | |
SU/Sahlgrenska | |
Gothenburg, Sweden, 41345 | |
University Hospital Lund | |
Lund, Sweden, 221 85 | |
Sundsvall Hospital | |
Sundsvall, Sweden, 851 86 | |
University Hospital MAS | |
Malmö, Sweden, 205 02 |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
Study ID Numbers: | 160001 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00161993 |
Health Authority: | Sweden: Medical Products Agency; Finland: National Agency for Medicines |
Gammaglobulin |
Lymphatic Diseases Antibodies Gamma-Globulins Agammaglobulinemia Immunoglobulins, Intravenous Hematologic Diseases |
Blood Protein Disorders Rho(D) Immune Globulin Lymphoproliferative Disorders Immunologic Deficiency Syndromes Immunoglobulins |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |