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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686759
• Other study ID #: GC5103-003_UDIV_P3b01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 18, 2023
• Est. completion date: September 2025

Study information

• Verified date: December 2022
• Source: GC Biopharma Corp
• Contact: Jayoung Shon
• Phone: 82-(0)31-260-1935
• Email: jyshon[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• Undiluted I.V.-Hepabig inj(GC5103)
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
• Diluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Biopharma Corp

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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