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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis B Infection
• Intervention / Treatment: Biological: GC1102 80,000 IU; Biological: GC1102 100,000 IU; Biological: I.V HBIG

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. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul ASAN Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study
2. Subject aged over 19 years at the time of consent provided
3. Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure
4. Subject with HBsAg(+)

Exclusion Criteria:

1. Subject with planned reoperation following liver transplantation
2. Subject with hemophilia
3. Subject with a history of venous or arterial thrombosis
4. Subject with HAV, HCV or HIV infection
5. Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
6. Subject with hemolytic or blood loss anemia
7. Subject with IgA deficiency
8. Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
9. Subject with moderate to severe kidney disease (serum creatinine > 20mg/dL or anuria, kidney failure or dialysis)
10. 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
11. Subject with severe heart failure(NYHA class III~IV), arrythmia requiring treatment
12. Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
13. Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
14. Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
15. Subject who had received estrogen or hormone alternative medicine
16. Pregnant or breast-feeding women
17. 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
18. Alcohol or drug abuse within 6 months
19. Subject who has participated in any other clinical trial within 30 days
20. Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test group 1; GC1102 80,000 IU	Biological: GC1102 80,000 IU; recombinant human hepatitis B immunoglobulin
EXPERIMENTAL: Test group 2; GC1102 100,000 IU	Biological: GC1102 100,000 IU; recombinant human hepatitis B immunoglobulin
ACTIVE_COMPARATOR: Control group; I.V HBIG	Biological: I.V HBIG; human anti-hepatitis B Immunoglobulin

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic(PK) parameters	serum drug titer	1 year
Area under curve(AUC)	area under the baseline corrected serum titer versus time curve from time 0 to time of the last measureable titer	1 year
clearance(CL)	clearance	1 year
Vdss	volume of distribution	1 year
Vdss/CL	effective half-life	1 year
Adverse events	Adverse events occured during clinical trials	1 year
Clinical abnormalities	Clinical laboratory test	1 year

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Seung-Gyu Lee, Ph.D, Seoul ASAN Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2018
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (ACTUAL): May 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hepatitis B immunoglobulin; HBV-related liver transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: GC1102_P2b/3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No