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

Hepatitis B Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304315
• Other study ID #: GC1102_P2
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2014
• Last updated: June 29, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2015
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection

Intervention

Biological:
• GC1102 50,000 IU
a recombinant hepatitis B immunoglobulin
• GC1102 80,000 IU
a recombinant hepatitis B immunoglobulin

Locations

Country	Name	City	State
Korea, Republic of	Seoul Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		28 weeks	Yes
Other	Clinical abnormalities in physical exam, vital signs, and/or laboratory		28 weeks	Yes
Other	Infusion reactions	Any adverse events occurred within 72 hours after intervention	72 hours	Yes
Other	Pharmacokinetic parameters of GC1102 titer (C trough, t 1/2b, AUC, C max, and T max)	C trough, t 1/2b, AUC, C max, and T max	Day 6, 28, 59, 84, 112, 140, 158, 196	No
Primary	Recurrence rate of Hepatitis B	Seroconversion rate of HBsAg or HBeAg	28 weeks	No
Secondary	Seroconversion rate of HBsAg or HBeAg		28 weeks	No
Secondary	Seroconversion time of HBsAg or HBeAg		28 weeks	No
Secondary	Overall survival rate		28 weeks	No
Secondary	Geometric mean titer (GMT) of HBV DNA		Day 6, 28, 59, 84, 112, 140, 158, 196	No
Secondary	Histological findings of hepatic graft	if available	Baseline	No
Secondary	Incidence rate of Anti-GC1102 Antibody		28 weeks	Yes
Secondary	Mutation rate of HBV DNA		28 weeks	Yes