A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorJongman Kim
About this trial
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.
Eligibility criteria
Qualifiers
Patients aged 19 years or older.
AST and ALT < 35IU/L
HBsAg: Negative
HBV DNA: Not detected
Disqualifiers
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
Trial design
Treatments tested in this trial
- Entecavell ODT
Treatment groups
82 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Jongman Kim
Lead sponsor
Samsung Medical Center
Sponsor institution
Source ClinicalTrials.gov