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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01421212
Eligibility Criteria:
Inclusion Criteria:
* Be 18 years old or greater, either male or female, of any ethnic background.
* Be positive for HBsAg. Patients may be either positive or negative for anti-HDV, HBeAg, and HBV DNA (non-PCR assay).
* Be diagnosed with HBV-induced liver disease including either:
* HBsAg positive cirrhosis, or
* HBsAg positive and presence of hepatocellular carcinoma (HCC) with no evidence of vascular invasion or extrahepatic spread, and either:
* a single tumor no larger than 5 cm in diameter, or
* no more than three tumors, the largest of which is no greater than 3 cm in diameter.
* Have received at least one dose of Lamivudine 100 mgs po qd prior to transplantation.
* Fulfill UNOS minimal listing criteria.
* Have received approval for liver transplantation at the respective participating center and are listed as Status 2 or 3 and felt to be within three months of liver transplantation.
* If requiring retransplantation for primary graft nonfunction or hepatic artery thrombosis, retransplantation must take place within the first four weeks of the initial transplant with no evidence of recurrent hepatitis B.
* Be able and willing to give written informed consent. In patients with Grade 3 or 4 hepatic encephalopathy, a legal guardian must be available to provide consent. In the case of a minor, a parent or guardian must provide consent.
* If a woman of childbearing potential, have a negative serum beta HCG pregnancy test within 14 days prior to starting Lamivudine therapy and within 14 days prior to transplant and agree to practice contraception during the study (a total of 36 weeks).
Exclusion Criteria:
* Eligible patients must not:
* Require retransplantation for recurrent hepatitis B.
* Have chronic hepatitis B liver disease with a history of breakthrough infection on Lamivudine
* Have other causes of liver disease including chronic hepatitis C.
* Have HCC and do not meet Inclusion Criterion #3, or who require systemic chemotherapy.
* Be seropositive for HIV infection.
* Be using experimental devices or receiving experimental drugs.
* Be participating in any other clinical treatment trial with an investigational drug within 30 days prior to liver transplantation or plan to receive another investigational drug during this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01421212
Study Brief:
Protocol Section:
NCT01421212