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

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: Recruiting
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Undiluted I.V.-Hepabig inj(GC5103); Biological: Diluted I.V.-Hepabig inj(GC5103)

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jiyoung Sin; Phone Number: 82-(0)31-260-9570; Email: jiyoung.sin@gccorp.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adverse events occurred during clinical trials	Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)	during 20 weeks post first Investigational product administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of Hepatitis B Surface Antigen(HBsAg)	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	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)	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)	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	Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit)	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)	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)	Screening, 0, 4, 8, 12, 16, and 20 weeks

Collaborators and Investigators

• Sponsor: GC Biopharma Corp

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Hepatitis B; Liver Diseases; Liver Transplantation; Hepatitis B Immunoglobulin
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B
• Other Study ID 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