This is a clinical 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. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG and be followed up till 28 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
186
recombinant human hepatitis B immunoglobulin
recombinant human hepatitis B immunoglobulin
human anti-hepatitis B Immunoglobulin
Seoul Asan Medical Center
Seoul, South Korea
Prevention Failure rate of HBV
Seroconversion rate of HBsAg or HBeAg, anti-HBs \< 500 IU/L
Time frame: 28weeks
Recurrence rate of HBV
Seroconversion rate of HBsAg or HBeAg
Time frame: 28weeks
Prophylactic failure rate of HBV
Seroconversion rate of HBsAg or HBeAg, anti-HBs \< 500 IU/L
Time frame: 28weeks
Recurrence duration
Seroconversion time of HBsAg or HBeAg
Time frame: 28weeks
Overall survival rate
survival rate during 1 year
Time frame: 1 year
Geometric mean titer of HBV DNA
Geometric mean titer(GMT) of HBV DNA
Time frame: 1 year
Change of anti-HBe
anti-hepatitis B e(HBe)
Time frame: 1 year
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