Hepatitis B Infection
Conditions
Keywords
HBV-related liver transplantation, Hepatitis B immunoglobulin
Brief summary
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.
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. 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.
Interventions
BIOLOGICALGC1102 80,000 IU
recombinant human hepatitis B immunoglobulin
BIOLOGICALGC1102 100,000 IU
recombinant human hepatitis B immunoglobulin
BIOLOGICALI.V HBIG
human anti-hepatitis B Immunoglobulin
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study 2. Subject aged over 19 years at the time of consent provided 3. Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure 4. Subject with HBsAg(+)
Exclusion criteria
1. Subject with planned reoperation following liver transplantation 2. Subject with hemophilia 3. Subject with a history of venous or arterial thrombosis 4. Subject with HAV, HCV or HIV infection 5. Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation 6. Subject with hemolytic or blood loss anemia 7. Subject with IgA deficiency 8. Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer 9. Subject with moderate to severe kidney disease (serum creatinine \> 20mg/dL or anuria, kidney failure or dialysis) 10. Subject with a history of transient ischemic attack(TIA), myocardial infarction(MI), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(PTA) or coronary artery bypass graft(CABG) within the last 6 months prior to the screening 11. Subject with severe heart failure(NYHA class III\ IV), arrythmia requiring treatment 12. Subject with known hypersensitivity (anaphylaxis) to any component of the study drug 13. Subject who had received other immunoglobulin product within the last 3 months prior to the study entry 14. Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry 15. Subject who had received estrogen or hormone alternative medicine 16. Pregnant or breast-feeding women 17. Woman of childbearing potential with positive pregnancy test confirmed by serum beta-human chorionic gonadotropin(B-HCG) test within 28 days prior to dosing by urine pregnancy or Subject who refused to use a reliable method of contraception 18. Alcohol or drug abuse within 6 months 19. Subject who has participated in any other clinical trial within 30 days 20. Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention Failure rate of HBV | 28weeks | Seroconversion rate of HBsAg or HBeAg, anti-HBs \< 500 IU/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of HBV | 28weeks | Seroconversion rate of HBsAg or HBeAg |
| Prophylactic failure rate of HBV | 28weeks | Seroconversion rate of HBsAg or HBeAg, anti-HBs \< 500 IU/L |
| Recurrence duration | 28weeks | Seroconversion time of HBsAg or HBeAg |
| Overall survival rate | 1 year | survival rate during 1 year |
| Geometric mean titer of HBV DNA | 1 year | Geometric mean titer(GMT) of HBV DNA |
| Change of anti-HBe | 1 year | anti-hepatitis B e(HBe) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic(PK) parameters | 1 year | serum drug titer |
| Area under curve(AUC) | 1 year | area under the baseline corrected serum titer versus time curve from time 0 to time of the last measureable titer |
| clearance(CL) | 1 year | clearance |
| Vdss | 1 year | volume of distribution |
| Vdss/CL | 1 year | effective half-life |
| Adverse events | 1 year | Adverse events occured during clinical trials |
| Clinical abnormalities | 1 year | Clinical laboratory test |
Countries
South Korea
Outcome results
None listed