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

Phase 2

Completed

• Conditions: Hepatitis B Infection

• Registration Number: NCT02304315
• Lead Sponsor: Green Cross Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-01
• Study Start: 2015-02
• Status Verified: 2015-12
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate of Hepatitis B	28 weeks	Seroconversion rate of HBsAg or HBeAg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of