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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00161993 |
Purpose
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: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| Finland | |
| Tampere University Hospital | |
| Tampere, Finland, 33 521 | |
| Turku University Central Hospital | |
| Turku, Finland, 205 20 | |
| Sweden | |
| SU/Sahlgrenska | |
| Gothenburg, Sweden, 41345 | |
| University Hospital Lund | |
| Lund, Sweden, 221 85 | |
| University Hospital MAS | |
| Malmö, Sweden, 205 02 | |
| Sundsvall Hospital | |
| Sundsvall, Sweden, 851 86 | |
| Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
More Information
| ClinicalTrials.gov Identifier: | NCT00161993 History of Changes |
| Other Study ID Numbers: | 160001 |
| Study First Received: | September 8, 2005 |
| Last Updated: | October 18, 2006 |
| Health Authority: | Sweden: Medical Products Agency; Finland: Finnish Medicines Agency |
|
Gammaglobulin |
|
Agammaglobulinemia Immunologic Deficiency Syndromes Blood Protein Disorders Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immune System Diseases |
Antibodies Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |