Hepatitis BPhase 3NCT05686759
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
A Phase 3 study testing Undiluted I.V.-Hepabig inj(GC5103) and Diluted I.V.-Hepabig inj(GC5103) in people with Hepatitis B, run by GC Biopharma Corp at 8 sites in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Undiluted I.V.-Hepabig inj(GC5103) and Diluted I.V.-Hepabig inj(GC5103)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 13 Apr 2023to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged ≥18 and <65 years at the time of signing the consent form
- 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
- HBsAg(+) before liver transplantation
- Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
Who cannot join
- Subject with history of anaphylaxis to any component of the investigational product
- Pregnant or breast-feeding women
- Deficiency of Immunoglobulin A
- Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
- Hemophilia
- Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
Show all 13Show fewer
- Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
- Subject received estrogen or hormone replacement therapy within 3 months before screening
- HBsAg or HBeAg or HBV DNA positive at screening
- 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
- Subject with history of drug abuse
- Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
- Subject who are determined disqualified to join clinical trials by investigator
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
- Recruiting
Chungnam National University Hospital
Daejeon, 35015
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
- Recruiting
Asan Medical Center
Seoul, Seoul, 05505
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital
Seoul, 03722
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
Ajou University Medical Center
Suwon, Gyeonggi-do, 16499
About this study
Official title: 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
- Conditions
- Hepatitis B
- Being tested
- Undiluted I.V.-Hepabig inj(GC5103), Diluted I.V.-Hepabig inj(GC5103)
- Keywords
- Hepatitis B, Liver Transplantation, Hepatitis B Immunoglobulin, Liver Diseases
- Medical subject headings
- Hepatitis B, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Undiluted I.V.-Hepabig inj(GC5103)Biological
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Diluted I.V.-Hepabig inj(GC5103)Biological
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
| Study group | Role | What they receive |
|---|---|---|
| Undiluted intravenous infusion of I.V.-Hepabig inj | Experimental | Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes Receives: Biological: Undiluted I.V.-Hepabig inj(GC5103) |
| Diluted intravenous infusion of I.V.-Hepabig inj | Active comparator | Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour Receives: Biological: Diluted I.V.-Hepabig inj(GC5103) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events occurred during clinical trials
Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)
Measured: during 20 weeks post first Investigational product administration
Secondary outcomes (7)
Positive rate of Hepatitis B Surface Antigen(HBsAg)
Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1~V7)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B Surface Antibody(Anti HBs) titer
Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1~V7)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Positive rate of Hepatitis B e Antigen(HBeAg)
Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1~V7)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Positive rate of Hepatitis B Virus DNA(HBV DNA)
Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1~V7)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Laboratory tests
Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Vital signs
Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Physical examination
Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit)
Measured: Screening, 0, 4, 8, 12, 16, and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start13 Apr 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686759
- Sponsor's protocol ID
- GC5103-003_UDIV_P3b01
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
- ClinicalTrials.gov ID
- NCT05686759
- Acronym / sponsor ID
- GC5103-003_UDIV_P3b01
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Liver Transplantation, Hepatitis B Immunoglobulin, Liver Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Undiluted intravenous infusion of I.V.-Hepabig inj | Experimental | Biological: Undiluted I.V.-Hepabig inj(GC5103)Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes |
| Diluted intravenous infusion of I.V.-Hepabig inj | Active comparator | Biological: Diluted I.V.-Hepabig inj(GC5103)Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged ≥18 and <65 years at the time of signing the consent form
- 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
- HBsAg(+) before liver transplantation
- Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
Key exclusion criteria (13 listed)
- Subject with history of anaphylaxis to any component of the investigational product
- Pregnant or breast-feeding women
- Deficiency of Immunoglobulin A
- Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
- Hemophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Undiluted I.V.-Hepabig inj(GC5103)undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit | Biological | Undiluted intravenous infusion of I.V.-Hepabig inj |
| Diluted I.V.-Hepabig inj(GC5103)Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit | Biological | Diluted intravenous infusion of I.V.-Hepabig inj |
Primary outcome
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)
7 secondary outcomes
Positive rate of Hepatitis B Surface Antigen(HBsAg)
Time frame: 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
Positive rate of Hepatitis B e Antigen(HBeAg)
Time frame: 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
Laboratory tests
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Vital signs
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Physical examination
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Undiluted I.V.-Hepabig inj(GC5103) and Diluted I.V.-Hepabig inj(GC5103) in people with Hepatitis B, run by GC Biopharma Corp at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyoung Sin (82-(0)31-260-9570, jiyoung.sin@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events occurred during clinical trials (time frame: during 20 weeks post first Investigational product administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.