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

GC5103-003_UDIV_P3b01

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

2023-01-18

2024-12-01

2025-09-01

Recruiting

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-02-14