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

Primary Purpose

Hepatitis B Infection

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GC1102 50,000 IU

GC1102 80,000 IU

About this trial

This is an interventional treatment trial for Hepatitis B Infection focused on measuring HBV-related liver transplantation, Hepatitis B Immuno Globulin

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GC1102 50,000 IU

GC1102 80,000 IU

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrence rate of Hepatitis B

Seroconversion rate of HBsAg or HBeAg

Secondary Outcome Measures

Seroconversion rate of HBsAg or HBeAg

Seroconversion time of HBsAg or HBeAg

Overall survival rate

Geometric mean titer (GMT) of HBV DNA

Histological findings of hepatic graft

if available

Incidence rate of Anti-GC1102 Antibody

Mutation rate of HBV DNA

Full Information

NCT ID

NCT02304315

First Posted

November 26, 2014

Last Updated

June 29, 2016

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02304315

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B Infection

Keywords

HBV-related liver transplantation, Hepatitis B Immuno Globulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GC1102 50,000 IU

Arm Type

Experimental

Arm Description

Arm Title

GC1102 80,000 IU

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

GC1102 50,000 IU

Intervention Description

a recombinant hepatitis B immunoglobulin

Intervention Type

Biological

Intervention Name(s)

GC1102 80,000 IU

Intervention Description

a recombinant hepatitis B immunoglobulin

Primary Outcome Measure Information:

Title

Recurrence rate of Hepatitis B

Description

Seroconversion rate of HBsAg or HBeAg

Time Frame

28 weeks

Secondary Outcome Measure Information:

Title

Seroconversion rate of HBsAg or HBeAg

Time Frame

28 weeks

Title

Seroconversion time of HBsAg or HBeAg

Time Frame

28 weeks

Title

Overall survival rate

Time Frame

28 weeks

Title

Geometric mean titer (GMT) of HBV DNA

Time Frame

Day 6, 28, 59, 84, 112, 140, 158, 196

Title

Histological findings of hepatic graft

Description

if available

Time Frame

Baseline

Title

Incidence rate of Anti-GC1102 Antibody

Time Frame

28 weeks

Title

Mutation rate of HBV DNA

Time Frame

28 weeks

Other Pre-specified Outcome Measures:

Title

Adverse events

Time Frame

28 weeks

Title

Clinical abnormalities in physical exam, vital signs, and/or laboratory

Time Frame

28 weeks

Title

Infusion reactions

Description

Any adverse events occurred within 72 hours after intervention

Time Frame

72 hours

Title

Pharmacokinetic parameters of GC1102 titer (C trough, t 1/2b, AUC, C max, and T max)

Description

C trough, t 1/2b, AUC, C max, and T max

Time Frame

Day 6, 28, 59, 84, 112, 140, 158, 196

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung-Gyu Lee, M.D.

Organizational Affiliation

Seoul Asan Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chang-Hee Lee, M.D.

Organizational Affiliation

GC Biopharma Corp

Official's Role

Study Director

Facility Information:

Facility Name

Seoul Asan Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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