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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Undiluted I.V.-Hepabig inj(GC5103); Biological: Diluted I.V.-Hepabig inj(GC5103)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events occurred during clinical trials	Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)	during 20 weeks post first Investigational product administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GC Biopharma Corp

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2023
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): September 1, 2025

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (ACTUAL): January 17, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Hepatitis B; Liver Diseases; Liver Transplantation; Hepatitis B Immunoglobulin
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis
• Other Study ID Numbers: GC5103-003_UDIV_P3b01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No