Immune Thrombocytopenia
Conditions
Brief summary
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.
Interventions
BIOLOGICALLIV-GAMMA SN Inj.
Sponsors
SK Plasma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate (CR or R) | 28 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects with complete response (CR) | 28 days | 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 |
| The percentage of subjects with response (R) | 28 days | 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 |
| Time to Response | 28 days | The time from the start of treatment to the time of achievement of CR or R |
| Duration of response | 28 days | the time from the achievement of CR or R to loss of CR or R |
| Bleeding | 28 days | Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP) |
Countries
South Korea
Outcome results
None listed