A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
NCT ID: NCT05686759
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
105 participants
INTERVENTIONAL
2023-04-13
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Undiluted intravenous infusion of I.V.-Hepabig inj
Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes
Undiluted I.V.-Hepabig inj(GC5103)
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
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
Diluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Interventions
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Undiluted I.V.-Hepabig inj(GC5103)
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Diluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
64 Years
ALL
No
Sponsors
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GC Biopharma Corp
INDUSTRY
Responsible Party
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Locations
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National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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GC5103-003_UDIV_P3b01
Identifier Type: -
Identifier Source: org_study_id
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