A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

Launched by SK PLASMA CO., LTD. · Sep 30, 2022

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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