Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT00395018
Eligibility Criteria:
Inclusion Criteria:
* Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA \< 172 IU/mL (approximately \< 1000 copies/mL) prior to liver transplant
* Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening
Exclusion Criteria:
* Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
* Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00395018
Study Brief:
Protocol Section:
NCT00395018