Hepatitis B
Conditions
Keywords
Hepatitis B, Liver Transplantation, Hepatitis B Immunoglobulin, Liver Diseases
Brief summary
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
Interventions
BIOLOGICALUndiluted I.V.-Hepabig inj(GC5103)
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
BIOLOGICALDiluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Sponsors
GC Biopharma Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 and \<65 years at the time of signing the consent form 2. Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence 3. HBsAg(+) before liver transplantation 4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
Exclusion criteria
1. Subject with history of anaphylaxis to any component of the investigational product 2. Pregnant or breast-feeding women 3. Deficiency of Immunoglobulin A 4. Clinically significant renal diseases (serum creatinine \>2.0mg/dL, anuria, renal failure or on dialysis at screening) 5. Hemophilia 6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus 7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer) 8. Subject received estrogen or hormone replacement therapy within 3 months before screening 9. HBsAg or HBeAg or HBV DNA positive at screening 10. Anti HBs titer less than below criteria at screening \<150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation \>500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation 11. Subject with history of drug abuse 12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening 13. Subject who are determined disqualified to join clinical trials by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events occurred during clinical trials | during 20 weeks post first Investigational product administration | Safety will be assessed throughout the study through clinical safety evaluations(Adverse events) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B Surface Antibody(Anti HBs) titer | Screening, 0, 4, 8, 12, 16, and 20 weeks | Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1\ V7) |
| Positive rate of Hepatitis B e Antigen(HBeAg) | Screening, 0, 4, 8, 12, 16, and 20 weeks | Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1\ V7) |
| Positive rate of Hepatitis B Virus DNA(HBV DNA) | Screening, 0, 4, 8, 12, 16, and 20 weeks | Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1\ V7) |
| Positive rate of Hepatitis B Surface Antigen(HBsAg) | Screening, 0, 4, 8, 12, 16, and 20 weeks | Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1\ V7) |
| Vital signs | Screening, 0, 4, 8, 12, 16, and 20 weeks | Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit) |
| Physical examination | Screening, 0, 4, 8, 12, 16, and 20 weeks | Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit) |
| Laboratory tests | Screening, 0, 4, 8, 12, 16, and 20 weeks | Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit) |
Countries
South Korea
Contacts
Primary ContactJiyoung Sin
Outcome results
None listed