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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Undiluted intravenous infusion of I.V.-Hepabig inj | Experimental | Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes |
|
| Diluted intravenous infusion of I.V.-Hepabig inj | Active Comparator | Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Undiluted I.V.-Hepabig inj(GC5103) | Biological | undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events occurred during clinical trials | Safety will be assessed throughout the study through clinical safety evaluations(Adverse events) | during 20 weeks post first Investigational product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Positive rate of Hepatitis B Surface Antigen(HBsAg) | Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1~V7) | Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Hepatitis B Surface Antibody(Anti HBs) titer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiyoung Sin | Contact | 82-(0)31-260-9570 | jiyoung.sin@gccorp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang-si | Gyeonggi-do | 10408 | South Korea | |
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| Diluted I.V.-Hepabig inj(GC5103) | Biological | Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit |
|
Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1~V7)
| Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Positive rate of Hepatitis B e Antigen(HBeAg) | Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1~V7) | Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Positive rate of Hepatitis B Virus DNA(HBV DNA) | Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1~V7) | Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Laboratory tests | Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit) | Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Vital signs | Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit) | Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Physical examination | Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit) | Screening, 0, 4, 8, 12, 16, and 20 weeks |
| Ajou University Medical Center |
| Recruiting |
| Suwon |
| Gyeonggi-do |
| 16499 |
| South Korea |
| Asan Medical Center | Recruiting | Seoul | Seoul | 05505 | South Korea |
| Inje University Haeundae Paik Hospital | Recruiting | Busan | 48108 | South Korea |
| Chungnam National University Hospital | Recruiting | Daejeon | 35015 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
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