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

SK Plasma

Status and phase

Completed

Phase 3

Conditions

Immune Thrombocytopenia

Treatments

Biological: LIV-GAMMA SN Inj.10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT05566990

IVIg10%_ITP_III_2019

Details and patient eligibility

About

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%.

Enrollment

34 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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