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

Sponsor

GC Biopharma Corp (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05686759

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Biological: Undiluted I.V.-Hepabig inj(GC5103) Biological: Diluted I.V.-Hepabig inj(GC5103)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Undiluted intravenous infusion of I.V.-Hepabig inj Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes	Biological: Undiluted I.V.-Hepabig inj(GC5103) undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Active Comparator: 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	Biological: Diluted I.V.-Hepabig inj(GC5103) Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Arm

Intervention/Treatment

Experimental: Undiluted intravenous infusion of I.V.-Hepabig inj

Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes

Biological: Undiluted I.V.-Hepabig inj(GC5103)

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

Active Comparator: 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

Biological: Diluted I.V.-Hepabig inj(GC5103)

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

Outcome Measures

Primary Outcome Measures

Adverse events occurred during clinical trials [during 20 weeks post first Investigational product administration]
Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)

Secondary Outcome Measures

Positive rate of Hepatitis B Surface Antigen(HBsAg) [Screening, 0 4, 8, 12, 16, and 20 weeks]
Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1~V7)
Hepatitis B Surface Antibody(Anti HBs) titer [Screening, 0 4, 8, 12, 16, and 20 weeks]
Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1~V7)
Positive rate of Hepatitis B e Antigen(HBeAg) [Screening,0 4, 8, 12, 16, and 20 weeks]
Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1~V7)
Positive rate of Hepatitis B Virus DNA(HBV DNA) [Screening, 0 4, 8, 12, 16, and 20 weeks]
Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1~V7)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged ≥19 and ≤65 years at the time of signing the consent form
HBsAg(+) before liver transplantation
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
Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen, and whole duration of administration of I.V.-Hepabig ing will not be exceeded 1 year while participating this study

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 and 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