Actively Recruiting
A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
Led by GC Biopharma Corp · Updated on 2025-06-25
105
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of undiluted intravenous infusion of I.V.-Hepabig injection in patients who have undergone liver transplantation due to hepatitis B-related end-stage liver disease. The study focuses on people aged 18 to 64 who have a history of liver transplant and have been treated to prevent hepatitis B recurrence. This phase 3b trial aims to compare two methods of administering the I.V.-Hepabig injection to better understand its impact on this patient group. Participants will be randomly assigned to one of two groups: one receiving an undiluted infusion of I.V.-Hepabig injection 10,000 International Units over about 30 minutes, and the other receiving a diluted infusion of the same dose mixed with Dextrose 5% in water over about 1 hour. Both treatments are biological therapies given intravenously, and the study compares these two infusion methods for safety and efficacy. During the study, participants will be closely monitored over 20 weeks following the first dose of the investigational product. Researchers will assess adverse events, hepatitis B markers including surface antigen and antibodies, liver virus DNA levels, vital signs, physical exams, and laboratory tests at screening and several time points throughout the study. This monitoring helps evaluate the treatment's safety and effects over time, with participant involvement lasting through the 20-week observation period.
CONDITIONS
Brief 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 Hepatitis B Surface Antigen (HBsAg) before liver transplantation
- Have received I.V.-Hepabig injection at least three times at 10,000 International Units per 4 weeks regimen
You will not qualify if you...
- History of anaphylaxis to any component of the investigational product
- Pregnant or breastfeeding women
- Immunoglobulin A deficiency
- Clinically significant kidney diseases (serum creatinine greater than 2.0 mg/dL, anuria, renal failure, or on dialysis at screening)
- Hemophilia
- Co-infection with Hepatitis A Virus, Hepatitis C Virus, or HIV
- History of malignancy within the last 5 years (except primary liver cancer)
- Received estrogen or hormone replacement therapy within 3 months before screening
- Positive for HBsAg, HBeAg, or HBV DNA at screening
- Anti-HBs titer below required levels at screening
- History of drug abuse
- Participated in another clinical study within 30 days before screening
- Determined unsuitable for clinical trial participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening visits include laboratory tests, vital signs, and physical examinations to determine eligibility.
Duration - 20 weeks post first investigational product administration
Participants receive either undiluted or diluted intravenous infusion of I.V.-Hepabig inj to prevent Hepatitis B recurrence after liver transplantation.
Visits at 0, 4, 8, 12, 16, and 20 weeks for infusions and assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here