Health TrialsbyHealthPanel

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

ConditionHepatitis B
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGC Biopharma Corp

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Undiluted I.V.-Hepabig inj(GC5103)

    Biological/Vaccine

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

  • Diluted I.V.-Hepabig inj(GC5103)

    Biological/Vaccine

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

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Undiluted intravenous infusion of I.V.-Hepabig injExperimental treatment 1 intervention
Group B: Diluted intravenous infusion of I.V.-Hepabig injActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events occurred during clinical trials

Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)

Time frame
during 20 weeks post first Investigational product administration

Secondary outcomes

1

Positive rate of Hepatitis B Surface Antigen(HBsAg)

Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1\~V7)

Time frame
Screening, 0, 4, 8, 12, 16, and 20 weeks
2

Hepatitis B Surface Antibody(Anti HBs) titer

Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1\~V7)

Time frame
Screening, 0, 4, 8, 12, 16, and 20 weeks
3

Positive rate of Hepatitis B e Antigen(HBeAg)

Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1\~V7)

Time frame
Screening, 0, 4, 8, 12, 16, and 20 weeks
4

Positive rate of Hepatitis B Virus DNA(HBV DNA)

Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1\~V7)

Time frame
Screening, 0, 4, 8, 12, 16, and 20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GC Biopharma Corp

Lead sponsor

Source ClinicalTrials.gov
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