A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

Study Overview
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Brief Summary
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The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with 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 duration of response, and the safety of LIV-GAMMA SN Inj.

Official Title
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A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Biological: LIV-GAMMA SN Inj.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ITP Mean screening platelet count of <30×10^9/L from 3 qualifying platelet counts performed within 14 days before the start of treatment, with no individual platelet count above 35×10^9/L. No other factors inducing ITP Stable doses of ITP active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study. Exclusion Criteria: Known for hypersensitivity reactions to blood products, intravenous immunoglobulin (IVIg) or immunoglobulin G Immunoglobulin A (IgA) deficiency Therapy with live attenuated virus vaccines 3 months before the first administration of LIV-GAMMA SN Inj. Administration of other investigational product 1 month before the first administration of LIV-GAMMA SN Inj. Administration of Rituximab 3 months before the first administration of LIV-GAMMA SN Inj. Treatment with anti-coagulants, which may affect the function of platelet Positive HIV, HBV, HCV 3-fold increase of ALT or AST compared to normal upper limit eCFR < 30mL/min/1.73m^2 History of deep vein thrombosis (DVT) or IVIg-induced thrombotic compliances Hemoglobin > 10g/dL

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIV-GAMMA SN Inj.<br> | Biological: LIV-GAMMA SN Inj.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate (CR or R) | The rate of subjects with complete response defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥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 without bleeding | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects with complete response (CR) | The percentage of subjects with CR defined as cases with a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding | 28 days | 
| The percentage of subjects with response (R) | The percentage of subjects with R defined as cases with a platelet count of ≥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 without bleeding | 28 days | 
| Time to Response | The time from the start of treatment to the time of achievement of CR or R | 28 days | 
| Duration of response | the time from the achievement of CR or R to loss of CR or R | 28 days | 
| Bleeding | Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP) | 28 days |