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RecruitingPhase 3NCT05686759

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

Sponsor

GC Biopharma Corp

Enrollment

105 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Hepatitis B

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

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria4

  • 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 Criteria13

  • 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

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Interventions

BIOLOGICALUndiluted I.V.-Hepabig inj(GC5103)

undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

BIOLOGICALDiluted I.V.-Hepabig inj(GC5103)

Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Locations(8)

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

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NCT05686759

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