A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

June 18, 2025 updated by: GC Biopharma Corp

A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Chungnam national university hospital
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 and <65 years at the time of signing the consent form
  2. Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence
  3. HBsAg(+) before liver transplantation
  4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen

Exclusion Criteria:

  1. Subject with history of anaphylaxis to any component of the investigational product
  2. Pregnant or breast-feeding women
  3. Deficiency of Immunoglobulin A
  4. Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
  5. Hemophilia
  6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
  7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
  8. Subject received estrogen or hormone replacement therapy within 3 months before screening
  9. HBsAg or HBeAg or HBV DNA positive at screening
  10. Anti HBs titer less than below criteria at screening <150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation >500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation
  11. Subject with history of drug abuse
  12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
  13. Subject who are determined disqualified to join clinical trials by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Undiluted intravenous infusion of I.V.-Hepabig inj
Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes
Biological: Undiluted I.V.-Hepabig inj(GC5103)
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Active Comparator: Diluted intravenous infusion of I.V.-Hepabig inj
Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour
Biological: Diluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events occurred during clinical trials
Time Frame: during 20 weeks post first Investigational product administration
Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)
during 20 weeks post first Investigational product administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive rate of Hepatitis B Surface Antigen(HBsAg)
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1~V7)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B Surface Antibody(Anti HBs) titer
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1~V7)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Positive rate of Hepatitis B e Antigen(HBeAg)
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1~V7)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Positive rate of Hepatitis B Virus DNA(HBV DNA)
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1~V7)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Laboratory tests
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Vital signs
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Physical examination
Time Frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit)
Screening, 0, 4, 8, 12, 16, and 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GC Biopharma Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GC5103-003_UDIV_P3b01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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