drugset / Trial / NCT07267208

A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients

NCT07267208 ↗

Phase 2 Not yet recruiting 82 enrolled Jongman Kim
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2025-12-01
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Entecavell ODT Unknown 0.5 mg Oral