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RECRUITINGPhase 3INTERVENTIONAL

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Undiluted I.V.-Hepabig inj(GC5103)

undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

BIOLOGICAL

Diluted I.V.-Hepabig inj(GC5103)

Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Locations (8)

National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea