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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Who Qualify As Treatment Responders | Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder. | Baseline thru Day 15 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve a platelet count > 50 x 109/L | Screening visit | |
| Time to achieve a platelet count > 50 x 109/L | Day 1 (initiation of treatment) | |
| Time to achieve a platelet count > 50 x 109/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | Czechia | |||||
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| Day 2 |
| Time to achieve a platelet count > 50 x 109/L | Day 5 |
| Time to achieve a platelet count > 50 x 109/L | Day 8 |
| Time to achieve a platelet count > 50 x 109/L | Day 11 |
| Time to achieve a platelet count > 50 x 109/L | Day 22 |
| Time to achieve a platelet count > 50 x 109/L | Day 15 |
| Time to achieve a platelet count > 50 x 109/L | Day 29 (study termination visit) |
| Duration of platelet response | Screening visit |
| Duration of platelet response | Day 1 (initiation visit) |
| Duration of platelet response | Day 2 |
| Duration of platelet response | Day 5 |
| Duration of platelet response | Day 8 |
| Duration of platelet response | Day 11 |
| Duration of platelet response | Day 15 |
| Duration of platelet response | Day 22 |
| Duration of platelet response | Day 29 (study termination visit) |
| Maximum Platelet Count | Screening visit |
| Maximum Platelet Count | Day 1 (initiation visit) |
| Maximum Platelet Count | Day 2 |
| Maximum Platelet Count | Day 5 |
| Maximum Platelet Count | Day 8 |
| Maximum Platelet Count | Day 11 |
| Maximum Platelet Count | Day 15 |
| Maximum Platelet Count | Day 22 |
| Maximum Platelet Count | Day 29 (study termination visit) |
| Number of Adverse Experiences | Throughout the study period of approximately 11 months |
| Hradec Králové |
| Czechia |
| Olomouc | Czechia |
| Prague | Czechia |
| Giessen | Germany |
| Halle | Germany |
| Debrecen | Hungary |
| Győr | Hungary |
| Szeged | Hungary |
| Szombathely | Hungary |
| Lodz | Poland |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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