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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Busan National University Hospital
Busan, South Korea
Bundang Seoul National University Hospital
Seongnam, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
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
Time frame: 28 days
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
Time frame: 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
Time frame: 28 days
Time to Response
The time from the start of treatment to the time of achievement of CR or R
Time frame: 28 days
Duration of response
the time from the achievement of CR or R to loss of CR or R
Time frame: 28 days
Bleeding
Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Yangsan Busan National University Hospital
Yangsan, South Korea