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

NCT ID: NCT05666453

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2024-07-01

Brief Summary

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

LIV-GAMMA SN Inj. administration after ABO-incompatible liver transplantation

Group Type: EXPERIMENTAL

LIV-GAMMA SN Inj.

Intervention Type: BIOLOGICAL

LIV-GAMMA SN Inj. is administered at a dose of 0.6 g/kg/day from anhepatic phase to Day 2 post-operative to patients undergoing ABO-incompatible liver transplantation as an experimental group.

Comparator group

No administration after ABO-incompatible liver transplantation

Group Type: OTHER

No intervention

Intervention Type: OTHER

None of investigational drugs are administered to patients.

Reference group

No administration after ABO-compatible liver transplantation

Group Type: OTHER

No intervention

Intervention Type: OTHER

None of investigational drugs are administered to patients.

Interventions

LIV-GAMMA SN Inj.

LIV-GAMMA SN Inj. is administered at a dose of 0.6 g/kg/day from anhepatic phase to Day 2 post-operative to patients undergoing ABO-incompatible liver transplantation as an experimental group.

Intervention Type: BIOLOGICAL

No intervention

None of investigational drugs are administered to patients.

Intervention Type: OTHER

Eligibility Criteria

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 multiorgan transplantation
• 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 or anaphylactic 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 Intravenous Immunoglobulin (IVIg) therapy
• Cerebrovascular 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 anemia
• Decreased cardiac functions
• Bacterial, fungal or viral infection making liver transplantation forbidden
• Intraductal or vascular infiltration observed in patients with hepatocellular carcinoma using medical imaging before liver transplantation
• Patients metastasized to organs except for liver or diagnosed cancer except for liver 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-derived products, 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.) during this study
• Patients who had received other investigational products within 8 weeks from complete consent or who are scheduled to receive other investigational products during this study
• Others whom the investigator considers ineligible for the study.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Plasma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nam-Joon Yi, MD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SK_LIV_ABO

Identifier Type: -

Identifier Source: org_study_id