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

GC Biopharma

Status and phase: Enrolling; Phase 3

Conditions: Hepatitis B

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05686759

GC5103-003_UDIV_P3b01

Details and patient eligibility

About

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

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥18 and <65 years at the time of signing the consent form
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

1. Subject with history of anaphylaxis to any component of the investigational product
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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Undiluted intravenous infusion of I.V.-Hepabig inj

Experimental group

Description:

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

Treatment:

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

Diluted intravenous infusion of I.V.-Hepabig inj

Active Comparator group

Description:

Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour

Treatment:

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