A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
- Conditions
- Hepatitis B
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
- Aged ≥18 and <65 years at the time of signing the consent form
- 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
- HBsAg(+) before liver transplantation
- Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
- Subject with history of anaphylaxis to any component of the investigational product
- Pregnant or breast-feeding women
- Deficiency of Immunoglobulin A
- Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
- Hemophilia
- Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
- Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
- Subject received estrogen or hormone replacement therapy within 3 months before screening
- HBsAg or HBeAg or HBV DNA positive at screening
- 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
- Subject with history of drug abuse
- Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
- Subject who are determined disqualified to join clinical trials by investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 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
- 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 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)
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 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)
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)
Laboratory tests Screening, 0, 4, 8, 12, 16, and 20 weeks Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit)
Vital signs Screening, 0, 4, 8, 12, 16, and 20 weeks Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit)
Physical examination Screening, 0, 4, 8, 12, 16, and 20 weeks Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit)
Trial Locations
- Locations (8)
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Center🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of