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CompletedNCT02304315Updated Jun 30, 2016

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

A Phase 2 interventional study of GC1102 50,000 IU and GC1102 80,000 IU in Hepatitis B Infection, sponsored by Green Cross Corporation. Completed at 1 site in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-30.

Sponsored by Green Cross Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis B Infection

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Keywords

  • HBV-related liver transplantation
  • Hepatitis B Immuno Globulin
03

In context

Hepatitis B

1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.

This study's enrollment of 40 is below the median of 120 across 1,191 interventional studies indexed under Hepatitis B.

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Lead sponsor

Green Cross Corporation is the lead sponsor of 63 studies on the registry; 1 is open to participants now.

Browse GC Biopharma Corp. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Given written informed consent
  • Aged 19 - 65 years
  • Expected liver transplantation related to hepatitis B
  • Positive HBsAg

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Recurrence rate of Hepatitis B

    Seroconversion rate of HBsAg or HBeAg

    Time frame: 28 weeks

Secondary outcomes

  1. Seroconversion rate of HBsAg or HBeAg

    Time frame: 28 weeks

  2. Seroconversion time of HBsAg or HBeAg

    Time frame: 28 weeks

  3. Overall survival rate

    Time frame: 28 weeks

  4. Geometric mean titer (GMT) of HBV DNA

    Time frame: Day 6, 28, 59, 84, 112, 140, 158, 196

  5. Histological findings of hepatic graft

    if available

    Time frame: Baseline

  6. Incidence rate of Anti-GC1102 Antibody

    Time frame: 28 weeks

  7. Mutation rate of HBV DNA

    Time frame: 28 weeks

Other outcomes

  1. Adverse events

    Time frame: 28 weeks

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

    Time frame: 28 weeks

  3. Infusion reactions

    Any adverse events occurred within 72 hours after intervention

    Time frame: 72 hours

  4. 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

    Time frame: Day 6, 28, 59, 84, 112, 140, 158, 196

07

Study locations

1 site
  • Seoul Asan Medical Center
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2014
First posted
Dec 1, 2014
Start
Feb 2015
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Jun 30, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02304315
Lead sponsor
Green Cross Corporation
Responsible party
Sponsor
First posted
Dec 1, 2014
Start date
Feb 2015
Primary completion
May 2016
Completion
May 2016
Last update
Jun 30, 2016

Study contacts

Sung-Gyu Lee, M.D.
principal investigator · Seoul Asan Medical Center
Chang-Hee Lee, M.D.
study director · GC Biopharma Corp

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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