A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
Phase 2
Completed
- Conditions
- Hepatitis B Infection
- Interventions
- Biological: GC1102 50,000 IUBiological: GC1102 80,000 IU
- Registration Number
- NCT02304315
- Lead Sponsor
- Green Cross Corporation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Given written informed consent
- Aged 19 - 65 years
- Expected liver transplantation related to hepatitis B
- Positive HBsAg
Exclusion Criteria
- Patients has participated in any other clinical trial within 30 days
- Patients who are scheduled re-operation for liver transplantation
- Patients with are co-infected with HAV, HCV or HIV
- History of malignant tumor within 5 years except primary liver cancer
- Patients with moderate or severe renal disorder (serum creatinine > 1.5 X ULM) or anuria, acute renal failure or dialysis
- Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
- History of anaphylaxis against active ingredient or excipients of study drug
- Patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
- Patients who had been treated with any other immuno globulin within 3 months
- Pregnant or breast-feeding women
- Women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
- Alcohol or drug abuse within 6 months
- Patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GC1102 50,000 IU GC1102 50,000 IU Anhepatic phase: 50,000 IU intravenous during surgery, Post-transplantation(1st week): 50,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 50,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 50,000 IU intravenous every 4 weeks. GC1102 80,000 IU GC1102 80,000 IU Anhepatic phase: 80,000 IU intravenous during surgery, Post-transplantation(1st week): 80,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 80,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 80,000 IU intravenous every 4 weeks.
- Primary Outcome Measures
Name Time Method Recurrence rate of Hepatitis B 28 weeks Seroconversion rate of HBsAg or HBeAg
- Secondary Outcome Measures
Name Time Method Incidence rate of Anti-GC1102 Antibody 28 weeks Seroconversion rate of HBsAg or HBeAg 28 weeks Overall survival rate 28 weeks Seroconversion time of HBsAg or HBeAg 28 weeks Geometric mean titer (GMT) of HBV DNA Day 6, 28, 59, 84, 112, 140, 158, 196 Histological findings of hepatic graft Baseline if available
Mutation rate of HBV DNA 28 weeks
Trial Locations
- Locations (1)
Seoul Asan Medical Center
🇰🇷Seoul, Korea, Republic of