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%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
Dong-A University Hospital
Busan, South Korea
Kosin University Gospel Hospital
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
...and 1 more locations
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
Time frame: 28 days
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
Time frame: 28 days
The percentage of subjects with response (R)
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
Time frame: 28 days
Time to response
The time from the treatment initiation to the day when complete response (CR) or response (R) is achieved
Time frame: 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
Time frame: 28 days
Bleeding
Bleeding assessment with ITP-BAT bleeding grading system
Time frame: 28 days
Adverse events
Time frame: 28 days
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