HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dose Selection(Step 1), Non-inferiority(Step 2), Phase II/III Clinical Trials to Evaluated the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102

Conditions
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Hepatitis B Infection

Intervention / Treatment
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* Biological: GC1102 80,000 IU
* Biological: GC1102 100,000 IU
* Biological: I.V HBIG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study Subject aged over 19 years at the time of consent provided Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure Subject with HBsAg(+) Exclusion Criteria: Subject with planned reoperation following liver transplantation Subject with hemophilia Subject with a history of venous or arterial thrombosis Subject with HAV, HCV or HIV infection Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation Subject with hemolytic or blood loss anemia Subject with IgA deficiency Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer Subject with moderate to severe kidney disease (serum creatinine > 20mg/dL or anuria, kidney failure or dialysis) 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 Subject with severe heart failure(NYHA class III IV), arrythmia requiring treatment Subject with known hypersensitivity (anaphylaxis) to any component of the study drug Subject who had received other immunoglobulin product within the last 3 months prior to the study entry Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry Subject who had received estrogen or hormone alternative medicine Pregnant or breast-feeding women 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 Alcohol or drug abuse within 6 months Subject who has participated in any other clinical trial within 30 days Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study

Ages Eligible for Study
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Minimum Age: 19 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: Test group 1<br>GC1102 80,000 IU | Biological: GC1102 80,000 IU<br>* recombinant human hepatitis B immunoglobulin<br>|
| Experimental: Test group 2<br>GC1102 100,000 IU | Biological: GC1102 100,000 IU<br>* recombinant human hepatitis B immunoglobulin<br>|
| Active Comparator: Control group<br>I.V HBIG | Biological: I.V HBIG<br>* human anti-hepatitis B Immunoglobulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention Failure rate of HBV | Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L | 28weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of HBV | Seroconversion rate of HBsAg or HBeAg | 28weeks | 
| Prophylactic failure rate of HBV | Seroconversion rate of HBsAg or HBeAg, anti-HBs < 500 IU/L | 28weeks | 
| Recurrence duration | Seroconversion time of HBsAg or HBeAg | 28weeks | 
| Overall survival rate | survival rate during 1 year | 1 year | 
| Geometric mean titer of HBV DNA | Geometric mean titer(GMT) of HBV DNA | 1 year | 
| Change of anti-HBe | anti-hepatitis B e(HBe) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV-related liver transplantation, Hepatitis B immunoglobulin