Actively Recruiting
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
Led by GC Biopharma Corp · Updated on 2025-06-25
105
Participants Needed
8
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to less than 65 years at the time of consent
- History of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer, or fulminant hepatic failure
- Positive for hepatitis B surface antigen (HBsAg) before liver transplantation
- Have received more than three doses of I.V.-Hepabig injection at 10,000 International Units in a 4-week regimen
You will not qualify if you...
- History of anaphylaxis to any component of the investigational product
- Pregnant or breastfeeding women
- Immunoglobulin A deficiency
- Significant kidney disease (serum creatinine >2.0 mg/dL, anuria, renal failure, or dialysis at screening)
- Hemophilia
- Co-infection with hepatitis A, hepatitis C, or HIV
- History of malignancy within the last 5 years (except primary liver cancer)
- Use of estrogen or hormone replacement therapy within 3 months before screening
- Positive for HBsAg, HBeAg, or HBV DNA at screening
- Anti-HBs titer below 150 IU/L if negative for HBeAg and HBV DNA before liver transplant, or below 500 IU/L if positive for either before transplant
- History of drug abuse
- Participation in another clinical study within 30 days before screening
- Determined by investigator as disqualified to join clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
2
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
3
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
4
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
5
Chungnam National University Hospital
Daejeon, South Korea, 35015
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
7
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
8
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Jiyoung Sin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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