A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation

The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj. administered for consecutive 3 days in adult subjects to prevent biliary complications after ABO incompatible adult to adult living donor liver transplantation (LDLT). The primary objective of this study is to determine the incidence rate of biliary complications for 48 weeks after liver transplantation. Incidence rate of transplant rejection, DSA, antibody reaction, CMV infection, infectious complications, DIHBS and recurrence rate of HCC as well as adverse events are assessed as additional efficacy and safety endpoints in this study.

Inclusion Criteria:Completed informed consent processMale or female aged ≥19 years and <75 yearsPatients scheduled hospitalization for liver transplantationExclusion Criteria:Patients who are scheduled or have history of re-transplantation or multiorgan transplantationPatients receiving living donor in emergencyPatients with Donor Specific Antibody (DSA) ≥ MFI 10,000 or Human Leukocyte Antigen (HLA) crossmatch (+) cytotoxic T-cell ≥ 1:32Patients with a history of biliary tract diseasePatients who plasma exchange is forbidden (with a history of allergic or anaphylactic reaction to FFP, albumin, heparin, etc.)Patients with a history of specific medical conditionsSevere renal failure (eGFR < 30 mL/min/1.73 m^2 at screening)Deep Vein Thrombosis (DVT) or thrombotic complications from Intravenous Immunoglobulin (IVIg) therapyCerebrovascular or cardiovascular disease (Hyperviscosity syndrome, Transient Ischemic Attack (TIA), Stroke, Thromboembolism, Unstable angina, etc.)Clinical state causing secondary immunodeficiency (Leukemia, Lymphoma, Multiple myeloma, HIV infection, Chronic or Cyclic neutropenia (Absolute neutrophil < 500/mm^3), etc.)Uncontrolled hypertension (Systolic blood pressure > 160 mmHg or Diastolic blood pressure > 100 mmHg)Hemolytic or hemorrhagic anemiaDecreased cardiac functionsBacterial, fungal or viral infection making liver transplantation forbiddenIntraductal or vascular infiltration observed in patients with hepatocellular carcinoma using medical imaging before liver transplantationPatients metastasized to organs except for liver or diagnosed cancer except for liver cancer and squamous cell carcinoma within 5 years from screeningPatients with sepsisPatients who had interventional therapy in blood vessels (hepatic vein, portal vein, hepatic artery, etc.) or bile ducts before LDLTPatients who have allergy or hypersensitivity to blood products, blood-derived products, IVIg or immunoglobulin G (IgG) productsPatients who have immunoglobulin A (IgA) deficiency or anti-IgA antibodyPatients who are pregnant and nursingPatients unwilling to use adequate method of contraception (hormonal methods, intrauterine device or intrauterine system, vasectomy, tubal ligation, etc.) during this studyPatients who had received other investigational products within 8 weeks from complete consent or who are scheduled to receive other investigational products during this study