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

Study Overview
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Brief Summary
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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

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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Undiluted I.V.-Hepabig inj(GC5103)
* Biological: Diluted I.V.-Hepabig inj(GC5103)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥19 and ≤65 years at the time of signing the consent form HBsAg(+) before liver transplantation 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 Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen, and whole duration of administration of I.V.-Hepabig ing will not be exceeded 1 year while participating this study Exclusion Criteria: Subject with history of anaphylaxis to any component of the investigational product Pregnant or breast-feeding women Deficiency of Immunoglobulin A Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening) Hemophilia Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus Subject with history of malignancy within the last 5 years (excluding primary liver cancer) Subject received estrogen or hormone replacement therapy within 3 months before screening HBsAg or HBeAg or HBV DNA positive at screening 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 and HBV DNA were positive(+) before liver transplantation Subject with history of drug abuse Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening Subject who are determined disqualified to join clinical trials by investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Undiluted intravenous infusion of I.V.-Hepabig inj<br>Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes | Biological: Undiluted I.V.-Hepabig inj(GC5103)<br>* undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit<br>|
| Active Comparator: Diluted intravenous infusion of I.V.-Hepabig inj<br>Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour | Biological: Diluted I.V.-Hepabig inj(GC5103)<br>* Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Liver Transplantation, Hepatitis B Immunoglobulin, Liver Diseases