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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
59
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.
None of investigational drugs are administered to patients.
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
Rate of biliary complications
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)
Time frame: 48 weeks
Rate of transplant rejection
The number and rate of subjects with transplant rejection for 48 weeks after liver transplantation
Time frame: 48 weeks
Rate of Donor Specific Antibody (DSA)
The number and rate of subjects with Donor Specific Antibody (DSA) for 48 weeks after liver transplantation
Time frame: 48 weeks
Rate of antibody reaction by ABO subtype
The number and rate of subjects with antibody reaction by ABO subtype analysis for 48 weeks after liver transplantation
Time frame: 48 weeks
Rate of Cytomegalovirus (CMV) infection
The number and rate of subjects with Cytomegalovirus (CMV) infection for 48 weeks after liver transplantation
Time frame: 48 weeks
Rate of infectious complications
The number and rate of subjects with infectious complications for 48 weeks after liver transplantation
Time frame: 48 weeks
Rate of Diffuse Intrahepatic Biliary Stricture (DIHBS)
The number and rate of subjects with Diffuse Intrahepatic Biliary Stricture (DIHBS) for 48 weeks after liver transplantation
Time frame: 48 weeks
Recurrence rate of Hepatocellular Carcinoma (HCC)
The recurrence rate of subjects with Hepatocellular Carcinoma (HCC) for 48 weeks after liver transplantation
Time frame: 48 weeks
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