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

NCT ID: NCT02304315

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-05-31

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.

Conditions

Hepatitis B Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GC1102 50,000 IU

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.

Group Type: EXPERIMENTAL

GC1102 50,000 IU

Intervention Type: BIOLOGICAL

a recombinant hepatitis B immunoglobulin

GC1102 80,000 IU

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.

Group Type: EXPERIMENTAL

GC1102 80,000 IU

Intervention Type: BIOLOGICAL

a recombinant hepatitis B immunoglobulin

Interventions

GC1102 50,000 IU

a recombinant hepatitis B immunoglobulin

Intervention Type: BIOLOGICAL

GC1102 80,000 IU

a recombinant hepatitis B immunoglobulin

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sung-Gyu Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul Asan Medical Center

Chang-Hee Lee, M.D.

Role: STUDY_DIRECTOR

GC Biopharma Corp

Locations

Seoul Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GC1102_P2

Identifier Type: -

Identifier Source: org_study_id