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

Phase 3

Recruiting

• Conditions: Hepatitis B
• Interventions: Biological: Undiluted I.V.-Hepabig inj(GC5103); Biological: Diluted I.V.-Hepabig inj(GC5103)

• Registration Number: NCT05686759
• Lead Sponsor: GC Biopharma Corp

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-17
• Study Start: 2023-01-18
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14
• Primary Completion: 2024-12
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged ≥19 and ≤65 years at the time of signing the consent form
2. HBsAg(+) before liver transplantation
3. 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
4. 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

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 and 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Undiluted intravenous infusion of I.V.-Hepabig inj	Undiluted I.V.-Hepabig inj(GC5103)	Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes
Diluted intravenous infusion of I.V.-Hepabig inj	Diluted I.V.-Hepabig inj(GC5103)	Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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 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)
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)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of