Skip to main content
OpenTrials
Completed

NCT Number: NCT02304315

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis B Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GC1102 50,000 IU

Biological

a recombinant hepatitis B immunoglobulin

GC1102 80,000 IU

Biological

a recombinant hepatitis B immunoglobulin

Primary outcomes

  1. Recurrence rate of Hepatitis B

    Time frame: 28 weeks

    Seroconversion rate of HBsAg or HBeAg

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

    Time frame: Baseline

    if available

  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

    Time frame: 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)

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

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

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2014
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.