Evaluating the safety and effectiveness of I.V.-Hepabig for post-liver transplant patients with Hepatitis B
A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
This study tests if a new treatment called I.V.-Hepabig can safely help liver transplant patients who had Hepatitis B by preventing the virus from coming back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | GC Biopharma Corp Industry-sponsored |
| Locations | 8 sites (Goyang-si, Gyeonggi-do and 7 other locations) |
| Trial ID | NCT05686759 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 who have tested positive for Hepatitis B and have a history of liver transplantation due to HBV-related liver disease.
Not a fit: Patients with a history of severe allergic reactions to the treatment components or those with certain co-infections or renal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of Hepatitis B recurrence in liver transplant patients, improving their long-term health outcomes.
How similar studies have performed: Previous studies have shown promise in using immunoglobulin therapies for Hepatitis B management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Goyang-si, Gyeonggi-do and 7 other locations
- 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)
- Severance Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jiyoung Sin
- Email: jiyoung.sin@gccorp.com
- Phone: 82-(0)31-260-9570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.