Evaluating the safety and effectiveness of I.V.-Hepabig for post-liver transplant patients with Hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of undiluted intravenous infusion of I.V.-Hepabig in patients who have undergone liver transplantation due to Hepatitis B-related complications. Participants will receive either undiluted or diluted I.V.-Hepabig injections to assess how well the treatment prevents the recurrence of Hepatitis B. The study aims to provide insights into the optimal dosing and administration of this immunoglobulin therapy in a post-transplant setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥18 and \<65 years at the time of signing the consent form
2. 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
3. HBsAg(+) before liver transplantation
4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen

Exclusion Criteria:

1. Subject with history of anaphylaxis to any component of the investigational product
2. Pregnant or breast-feeding women
3. Deficiency of Immunoglobulin A
4. Clinically significant renal diseases (serum creatinine \>2.0mg/dL, anuria, renal failure or on dialysis at screening)
5. Hemophilia
6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
8. Subject received estrogen or hormone replacement therapy within 3 months before screening
9. HBsAg or HBeAg or HBV DNA positive at screening
10. 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
11. Subject with history of drug abuse
12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
13. Subject who are determined disqualified to join clinical trials by investigator

Where it's running

• National Cancer Center
  Goyang-si, Gyeonggi-do, South Korea Recruiting
• Ajou University Medical Center
  Suwon, Gyeonggi-do, South Korea Recruiting
• Asan Medical Center
  Seoul, Seoul, South Korea Recruiting
• Inje University Haeundae Paik Hospital
  Busan, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jiyoung Sin
• Email: jiyoung.sin@gccorp.com
• Phone: 82-(0)31-260-9570

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.