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The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj.10% administered for 2 days in adult subjects with primary immune thrombocytopenia (ITP). The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10^9/L and at least a 2-fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including time to response and duration of response, and the safety of LIV-GAMMA SN Inj.10%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIV-GAMMA SN Inj.10% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIV-GAMMA SN Inj.10% | Biological | LIV-GAMMA SN Inj. 10% is administered intravenously at a dose of 1 g/kg daily for 2 consecutive days to patients with primary immune thrombocytopenia. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate (CR or R) | The rate of subjects with complete response (CR) defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding or response (R) defined as cases with a platelet count ≥30×10^9/L and at least a 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects with complete response (CR) | The percentage of subjects with complete response (CR) defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding | 28 days |
| The percentage of subjects with response (R) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Wook Lee, MD | The Catholic University of Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea | ||||
| Kosin University Gospel Hospital |
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The percentage of subjects with response (R) defined as cases with a platelet count ≥30×10^9/L and at least a 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding |
| 28 days |
| Time to response | The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved | 28 days |
| Duration of response | The time from the achievement of complete response (CR) or response (R) to the day when loss of complete response (CR) or response (R) is achieved | 28 days |
| Bleeding | Bleeding assessment with ITP-BAT bleeding grading system | 28 days |
| Adverse events | 28 days |
| Busan |
| South Korea |
| Pusan National University Hospital | Busan | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | South Korea |
| 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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