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

• Sponsor: Green Cross Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02304315
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Infection	Biological: GC1102 50,000 IU; Biological: GC1102 80,000 IU	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: GC1102 50,000 IU; a recombinant hepatitis B immunoglobulin
Experimental: 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.	Biological: GC1102 80,000 IU; a recombinant hepatitis B immunoglobulin

Outcome Measures

Primary Outcome Measures

1. Recurrence rate of Hepatitis B [28 weeks]

   Seroconversion rate of HBsAg or HBeAg

Secondary Outcome Measures

1. Seroconversion rate of HBsAg or HBeAg [28 weeks]

2. Seroconversion time of HBsAg or HBeAg [28 weeks]

3. Overall survival rate [28 weeks]

4. Geometric mean titer (GMT) of HBV DNA [Day 6, 28, 59, 84, 112, 140, 158, 196]

5. Histological findings of hepatic graft [Baseline]

   if available

6. Incidence rate of Anti-GC1102 Antibody [28 weeks]

7. Mutation rate of HBV DNA [28 weeks]

Other Outcome Measures

1. Adverse events [28 weeks]

2. Clinical abnormalities in physical exam, vital signs, and/or laboratory [28 weeks]

3. Infusion reactions [72 hours]

   Any adverse events occurred within 72 hours after intervention

4. Pharmacokinetic parameters of GC1102 titer (C trough, t 1/2b, AUC, C max, and T max) [Day 6, 28, 59, 84, 112, 140, 158, 196]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Green Cross Corporation

Investigators

• Principal Investigator: Sung-Gyu Lee, M.D., Seoul Asan Medical Center
• Study Director: Chang-Hee Lee, M.D., GC Biopharma Corp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Green Cross Corporation
• ClinicalTrials.gov Identifier: NCT02304315
• Other Study ID Numbers: GC1102_P2
• First Posted: Dec 1, 2014
• Last Update Posted: Jun 30, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Green Cross Corporation: HBV-related liver transplantation; Hepatitis B Immuno Globulin
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis

Study Results

No Results Posted as of Jun 30, 2016