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

Inclusion Criteria:

• Completed informed consent process

• Male or female aged ≥19 years and <75 years

• Patients scheduled hospitalization for liver transplantation

Exclusion Criteria:

• Patients who are scheduled or have history of re-transplantation or multiorgantransplantation

• Patients receiving living donor in emergency

• Patients with Donor Specific Antibody (DSA) ≥ MFI 10,000 or Human Leukocyte Antigen (HLA) crossmatch (+) cytotoxic T-cell ≥ 1:32

• Patients with a history of biliary tract disease

• Patients who plasma exchange is forbidden (with a history of allergic oranaphylactic reaction to FFP, albumin, heparin, etc.)

• Patients with a history of specific medical conditions

• Severe renal failure (eGFR < 30 mL/min/1.73 m^2 at screening)

• Deep Vein Thrombosis (DVT) or thrombotic complications from IntravenousImmunoglobulin (IVIg) therapy

• Cerebrovascular or cardiovascular disease (Hyperviscosity syndrome, TransientIschemic Attack (TIA), Stroke, Thromboembolism, Unstable angina, etc.)

• Clinical state causing secondary immunodeficiency (Leukemia, Lymphoma, Multiplemyeloma, HIV infection, Chronic or Cyclic neutropenia (Absolute neutrophil < 500/mm^3), etc.)

• Uncontrolled hypertension (Systolic blood pressure > 160 mmHg or Diastolicblood pressure > 100 mmHg)

• Hemolytic or hemorrhagic anemia

• Decreased cardiac functions

• Bacterial, fungal or viral infection making liver transplantation forbidden

• Intraductal or vascular infiltration observed in patients with hepatocellularcarcinoma using medical imaging before liver transplantation

• Patients metastasized to organs except for liver or diagnosed cancer except forliver cancer and squamous cell carcinoma within 5 years from screening

• Patients with sepsis

• Patients who had interventional therapy in blood vessels (hepatic vein, portal vein,hepatic artery, etc.) or bile ducts before LDLT

• Patients who have allergy or hypersensitivity to blood products, blood-derivedproducts, IVIg or immunoglobulin G (IgG) products

• Patients who have immunoglobulin A (IgA) deficiency or anti-IgA antibody

• Patients who are pregnant and nursing

• Patients unwilling to use adequate method of contraception (hormonal methods,intrauterine device or intrauterine system, vasectomy, tubal ligation, etc.) duringthis study

• Patients who had received other investigational products within 8 weeks fromcomplete consent or who are scheduled to receive other investigational productsduring this study

• Others whom the investigator considers ineligible for the study.