Phase
Condition
Hepatitis
Hepatitis B
Treatment
Undiluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103)
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 liverdisease such as cirrhosis, liver cancer and fulminant hepatic failure and receivedtreatment 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
Exclusion
Exclusion Criteria:
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, renalfailure or on dialysis at screening)
Hemophilia
Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human ImmunodeficiencyVirus
Subject with history of malignancy within the last 5 years (excluding primary livercancer)
Subject received estrogen or hormone replacement therapy within 3 months beforescreening
HBsAg or HBeAg or HBV DNA positive at screening
Anti HBs titer less than below criteria at screening <150 IU/L for subject whoseHBeAg and HBV DNA were negative(-) before liver transplantation >500 IU/L forsubject 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 ofinvestigational product) before screening
Subject who are determined disqualified to join clinical trials by investigator
Study Design
Connect with a study center
National Cancer Center
Goyang-si, Gyeonggi-do 10408
Korea, Republic ofActive - Recruiting
Ajou University Medical Center
Suwon, Gyeonggi-do 16499
Korea, Republic ofActive - Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofActive - Recruiting
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting

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