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
1 other identifier
interventional
105
1 country
8
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2023
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
June 25, 2025
June 1, 2025
3.2 years
December 2, 2022
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Positive rate of Hepatitis B Surface Antigen(HBsAg)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Hepatitis B Surface Antibody(Anti HBs) titer
Screening, 0, 4, 8, 12, 16, and 20 weeks
Positive rate of Hepatitis B e Antigen(HBeAg)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Positive rate of Hepatitis B Virus DNA(HBV DNA)
Screening, 0, 4, 8, 12, 16, and 20 weeks
Laboratory tests
Screening, 0, 4, 8, 12, 16, and 20 weeks
- +2 more secondary outcomes
Study Arms (2)
Undiluted intravenous infusion of I.V.-Hepabig inj
EXPERIMENTALUndiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes
Diluted intravenous infusion of I.V.-Hepabig inj
ACTIVE COMPARATORDiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour
Interventions
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, 16499, South Korea
Asan Medical Center
Seoul, Seoul, 05505, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2022
First Posted
January 17, 2023
Study Start
April 13, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share