Status:
COMPLETED
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
Lead Sponsor:
Green Cross Corporation
Conditions:
Hepatitis B Infection
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
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 opti...
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 s...
Eligibility Criteria
Inclusion
- Given written informed consent
- Aged 19 - 65 years
- Expected liver transplantation related to hepatitis B
- Positive HBsAg
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02304315
Start Date
February 1 2015
End Date
May 1 2016
Last Update
June 30 2016
Active Locations (1)
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1
Seoul Asan Medical Center
Seoul, South Korea