NCT05686759 A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
| NCT ID | NCT05686759 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GC Biopharma Corp |
| Condition | Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 105 participants in total. It began in 2023-04-13 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05686759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05686759 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 105 participants.
Is NCT05686759 currently recruiting?
Yes, NCT05686759 is actively recruiting participants. Contact the research team at jiyoung.sin@gccorp.com for enrollment information.
Where is the NCT05686759 trial being conducted?
This trial is being conducted at Goyang-si, South Korea, Suwon, South Korea, Seoul, South Korea, Busan, South Korea and 4 additional locations.
Who is sponsoring the NCT05686759 clinical trial?
NCT05686759 is sponsored by GC Biopharma Corp. The trial plans to enroll 105 participants.