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

Phase 2

Terminated

• Conditions: Liver Transplantation

• Registration Number: NCT05666453
• Lead Sponsor: SK Plasma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-17
• Study First Posted: 2022-12-27
• Primary Completion: 2024-05-07
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-29
• Last Update Posted: 2024-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of biliary complications	48 weeks	The number and rate of subjects with biliary complications including cholangitis, biliary leaks or biliary strictures for 48 weeks after liver transplantation (Experimental group vs. Comparator group)

Secondary Outcome Measures

Name	Time	Method
Rate of transplant rejection	48 weeks	The number and rate of subjects with transplant rejection for 48 weeks after liver transplantation
Recurrence rate of Hepatocellular Carcinoma (HCC)	48 weeks	The recurrence rate of subjects with Hepatocellular Carcinoma (HCC) for 48 weeks after liver transplantation
Rate of Donor Specific Antibody (DSA)	48 weeks	The number and rate of subjects with Donor Specific Antibody (DSA) for 48 weeks after liver transplantation
Rate of antibody reaction by ABO subtype	48 weeks	The number and rate of subjects with antibody reaction by ABO subtype analysis for 48 weeks after liver transplantation
Rate of Cytomegalovirus (CMV) infection	48 weeks	The number and rate of subjects with Cytomegalovirus (CMV) infection for 48 weeks after liver transplantation
Rate of infectious complications	48 weeks	The number and rate of subjects with infectious complications for 48 weeks after liver transplantation
Rate of Diffuse Intrahepatic Biliary Stricture (DIHBS)	48 weeks	The number and rate of subjects with Diffuse Intrahepatic Biliary Stricture (DIHBS) for 48 weeks after liver transplantation