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The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blisibimod | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blisibimod | Biological |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a durable platelet count of 50 billion platelets per liter or higher over the last weeks of treatment under conditions of decreased concomitant steroid medication. | 24 weeks | |
| Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Other |
|
| 24 weeks |
| Change in background corticosteroid dose. | baseline to 24 weeks |
| Percentage of subjects requiring rescue therapy. | 24 weeks |
| Time to treatment failure. | 24 weeks |
| Change in bleeding risk. | baseline to 24 weeks |
| Safety profile (AEs, vitals signs, labs) | 24 weeks |
| Biomarker changes from baseline. | baseline to 24 weeks |
| 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 |
|---|---|
| C573858 | AMG623 peptibody |
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