A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liv… (NCT07267208) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
82 participantsStarted 2025-12-01
Plain-language summary
This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function.
After providing written informed consent, participants will undergo screening assessments to determine eligibility based on the inclusion and exclusion criteria. Eligible participants who receive the investigational product will visit the study site at predetermined time points over a 48-week period to complete the scheduled study procedures.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Patients aged 19 years or older.
✓. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:
✓. AST and ALT \< 35IU/L
✓. HBsAg: Negative
✓. HBV DNA: Not detected
✓. Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.
✓. Patients with a tacrolimus trough level maintained between 3-10 ng/mL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.
Exclusion criteria
✕. Patients who have undergone transplantation of organs other than the liver or re-transplantation.
✕. Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
✕. Patients with concurrent viral infections (HCV, HIV).
✕. Patients with eGFR \<30 or those undergoing dialysis
✕. Pregnant or breastfeeding women.
✕. Patients or their spouses/partners who do not agree to use medically acceptable and appropriate contraception methods\* during the clinical trial period.