A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients

Study Overview
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Brief Summary
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This is a proof-of-concept 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. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.

Official Title
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A Randomized, Open-label, Single-center, Phase II Trial to Explore the Safety and Efficacy of GC1102 and Determine Its Optimal Dose After Intravenous Administration in HBV-related Liver Transplant Recipients

Conditions
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Hepatitis B Infection

Intervention / Treatment
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* Biological: GC1102 50,000 IU
* Biological: GC1102 80,000 IU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Given written informed consent Aged 19 - 65 years Expected liver transplantation related to hepatitis B Positive HBsAg Exclusion Criteria: Patients has participated in any other clinical trial within 30 days Patients who are scheduled re-operation for liver transplantation Patients with are co-infected with HAV, HCV or HIV History of malignant tumor within 5 years except primary liver cancer Patients with moderate or severe renal disorder (serum creatinine > 1.5 X ULM) or anuria, acute renal failure or dialysis Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months History of anaphylaxis against active ingredient or excipients of study drug Patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months Patients who had been treated with any other immuno globulin within 3 months Pregnant or breast-feeding women Women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study Alcohol or drug abuse within 6 months Patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC1102 50,000 IU<br>Anhepatic phase: 50,000 IU intravenous during surgery, Post-transplantation(1st week): 50,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 50,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 50,000 IU intravenous every 4 weeks. | Biological: GC1102 50,000 IU<br>* a recombinant hepatitis B immunoglobulin<br>|
| Experimental: GC1102 80,000 IU<br>Anhepatic phase: 80,000 IU intravenous during surgery, Post-transplantation(1st week): 80,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 80,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 80,000 IU intravenous every 4 weeks. | Biological: GC1102 80,000 IU<br>* a recombinant hepatitis B immunoglobulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of Hepatitis B | Seroconversion rate of HBsAg or HBeAg | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate of HBsAg or HBeAg |  | 28 weeks | 
| Seroconversion time of HBsAg or HBeAg |  | 28 weeks | 
| Overall survival rate |  | 28 weeks | 
| Geometric mean titer (GMT) of HBV DNA |  | Day 6, 28, 59, 84, 112, 140, 158, 196 | 
| Histological findings of hepatic graft | if available | Baseline | 
| Incidence rate of Anti-GC1102 Antibody |  | 28 weeks | 
| Mutation rate of HBV DNA |  | 28 weeks | 

 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 Immuno Globulin