Menu
Recruiting NCT05686759

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

Phase III Interventional Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Undiluted I.V.-Hepabig inj(GC5103), Diluted I.V.-Hepabig inj(GC5103).
Who it may be relevant to
Registry conditions: Hepatitis B. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients

Overview

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

Interventions

  • Biological Undiluted I.V.-Hepabig inj(GC5103)
    undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
  • Biological Diluted I.V.-Hepabig inj(GC5103)
    Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Primary outcome measures

  • Adverse events occurred during clinical trials [Time frame: during 20 weeks post first Investigational product administration]
Secondary outcome measures (7)
  • Positive rate of Hepatitis B Surface Antigen(HBsAg) [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]
  • Hepatitis B Surface Antibody(Anti HBs) titer [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]
  • Positive rate of Hepatitis B e Antigen(HBeAg) [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]
  • Positive rate of Hepatitis B Virus DNA(HBV DNA) [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]
  • Laboratory tests [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]
  • Vital signs [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]
  • Physical examination [Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

South Korea · 8 centers
  • National Cancer Center — Goyang-si
  • Ajou University Medical Center — Suwon
  • Asan Medical Center — Seoul
  • Inje University Haeundae Paik Hospital — Busan
  • Chungnam National University Hospital — Daejeon
  • Seoul National University Hospital — Seoul
  • Severance Hospital — Seoul
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT05686759 · GC5103-003_UDIV_P3b01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗