a clinical study to evaluate the efficacy and safety of liv-gamma sn inj.10% in primary immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia

Summary: 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%.


Eligibility criteria:
inclusion criteria: * completed informed consent process * male or female aged ≥19 years * diagnosis of chronic itp (≥12 months since diagnosis) * 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 * if the patient is taking corticosteroid, attenuated androgen, cyclophosphamide, azathioprine or other drugs for itp, the treatment regimen and dose should be stable at least 1 month prior to screening and should be lasted during this study * females of child-bearing potential with a negative urine pregnancy test and who agree with contraception during this study exclusion criteria: * patients who have allergy or hypersensitivity to blood products, blood-derived products, intravenous immunoglobulin (ivig) or immunoglobulin g (igg) * patients who have immunoglobulin a (iga) deficiency * patients who were immunized with live attenuated vaccines within 12 months from the first administration of liv-gamma sn inj.10% * patients who had received ivig or blood/blood-derived products within 1 month from the first administration of liv-gamma sn inj.10% * patients who had received other investigational products within 1 month from the first administration of liv-gamma sn inj.10% * patients who had received rituximab within 3 months from the first administration of liv-gamma sn inj.10% * patients who were taking anticoagulants or other agents related to platelet function (e.g., aspirin, other nsaid) at the time of screening * patients who are pregnant and nursing * patients who are positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) at the time of screening * patients who have 3-fold higher levels of alanine transaminase (alt), aspartate transaminase (ast) than the upper limit of normal at the time of screening * patients who suffered from severe renal impairment (egfr\<30 ml/min/1.73 m\^2 at the time of screening) * patients who had history of deep vein thrombosis (dvt) or thrombotic complications against ivig therapy * patients who had history of neurovascular or cardiovascular disorders (e.g., blood hyperviscosity, transient ischemic attack (tia), stroke, other thromboembolism, unstable angina) * patients who have an ongoing history of acute or chronic condition that affect to the participation of this study * patients who have an ongoing history of medical condition inducing secondary immune deficiency (e.g., leukemia, lymphoma, multiple myeloma, hiv infection, chronic or cyclic neutropenia (absolute neutrophil count\<500/mm\^3) * patients who are suffering from hypertension (systolic blood pressure\>160 mmhg or diastolic blood pressure\>100 mmhg) * patients who have hemoglobin level≤10 g/dl at the time of screening