A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
- Conditions
- Immune Thrombocytopenia
- Interventions
- Biological: LIV-GAMMA SN Inj.
- Registration Number
- NCT03164915
- Lead Sponsor
- SK Plasma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LIV-GAMMA SN Inj. LIV-GAMMA SN Inj. -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to Response 28 days The time from the start of treatment to the time of achievement of CR or R
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
Duration of response 28 days the time from the achievement of CR or R to loss of CR or R
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
Bleeding 28 days Bleeding assessment using ITP-BAT (bleeding assessment tool for ITP)
Trial Locations
- Locations (6)
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Bundang Seoul National University Hospital
🇰🇷Seongnam, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Busan National University Hospital
🇰🇷Busan, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yangsan Busan National University Hospital
🇰🇷Yangsan, Korea, Republic of