A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
Key facts
- Where
- Busan, Daejeon, Goyang-si, Seoul, and Suwon, South KoreaSee the 8 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT05686759, who can take part
Where in South Korea
- Inje University Haeundae Paik HospitalBusan, South KoreaTaking people
- Chungnam National University HospitalDaejeon, South KoreaTaking people
- National Cancer CenterGoyang-si, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaTaking people
- Ajou University Medical CenterSuwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GC Biopharma Corp
- Trial code
- NCT05686759
- Record updated
- 25 June 2025
- Original description
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 patientsRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: Subject with history of anaphylaxis to any component of the investigational product; Subject received estrogen or hormone replacement therapy within 3 months before screening; Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening; 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); 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; Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening); Pregnant or breast-feeding women; Deficiency of Immunoglobulin A; Hemophilia; Subject who are determined disqualified to join clinical trials by investigator.