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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
105
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGAjou University Medical Center
Suwon, Gyeonggi-do, South Korea
RECRUITINGAsan Medical Center
Seoul, Seoul, South Korea
Adverse events occurred during clinical trials
Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)
Time frame: during 20 weeks post first Investigational product administration
Positive rate of Hepatitis B Surface Antigen(HBsAg)
Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1\~V7)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Laboratory tests
Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit)
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
Vital signs
Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit)
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inje University Haeundae Paik Hospital
Busan, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGPhysical examination
Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit)
Time frame: Screening, 0, 4, 8, 12, 16, and 20 weeks