Hepatitis B Infection
Conditions
Keywords
HBV-related liver transplantation, Hepatitis B Immuno Globulin
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.
Interventions
BIOLOGICALGC1102 50,000 IU
a recombinant hepatitis B immunoglobulin
BIOLOGICALGC1102 80,000 IU
a recombinant hepatitis B immunoglobulin
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of Hepatitis B | 28 weeks | Seroconversion rate of HBsAg or HBeAg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mutation rate of HBV DNA | 28 weeks | — |
| Overall survival rate | 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 |
| Incidence rate of Anti-GC1102 Antibody | 28 weeks | — |
| Seroconversion rate of HBsAg or HBeAg | 28 weeks | — |
| Seroconversion time of HBsAg or HBeAg | 28 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infusion reactions | 72 hours | Any adverse events occurred within 72 hours after intervention |
| Pharmacokinetic parameters of GC1102 titer (C trough, t 1/2b, AUC, C max, and T max) | Day 6, 28, 59, 84, 112, 140, 158, 196 | C trough, t 1/2b, AUC, C max, and T max |
| Clinical abnormalities in physical exam, vital signs, and/or laboratory | 28 weeks | — |
| Adverse events | 28 weeks | — |
Countries
South Korea
Outcome results
None listed