This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
GC1102 is a new recombinant hepatitis B immunoglobulin (HBIg) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIg derived from blood plasma of human donors. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
a recombinant hepatitis B immunoglobulin
a recombinant hepatitis B immunoglobulin
Seoul Asan Medical Center
Seoul, South Korea
Recurrence rate of Hepatitis B
Seroconversion rate of HBsAg or HBeAg
Time frame: 28 weeks
Seroconversion rate of HBsAg or HBeAg
Time frame: 28 weeks
Seroconversion time of HBsAg or HBeAg
Time frame: 28 weeks
Overall survival rate
Time frame: 28 weeks
Geometric mean titer (GMT) of HBV DNA
Time frame: Day 6, 28, 59, 84, 112, 140, 158, 196
Histological findings of hepatic graft
if available
Time frame: Baseline
Incidence rate of Anti-GC1102 Antibody
Time frame: 28 weeks
Mutation rate of HBV DNA
Time frame: 28 weeks
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