A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
Hepatitis B Infection
About this trial
This is an interventional treatment trial for Hepatitis B Infection focused on measuring HBV-related liver transplantation, Hepatitis B Immuno Globulin
Eligibility Criteria
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
Sites / Locations
- Seoul Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
GC1102 50,000 IU
GC1102 80,000 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.
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.