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

ConditionsHepatitis B VirusLiver Transplant
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Entecavell ODT

    Drug

    Entecavir ODT is administered once every day with 0.5mg PO for 48 weeks.

Treatment groups

82 Participants
are divided into 1 treatment group
Group A: Entecavell ODTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in eGFR at week 48

Change in eGFR from baseline to week 48 following ETV-ODT conversion

Time frame
Baseline to week 48

Secondary outcomes

1

Change in Creatinine, cystatin C profile

Change in Creatinine, cystatin C profile from baseline to week 48 following ETV-ODT conversion

Time frame
Baseline to week 48
2

Change in CKD stage

Change in the proportion of participants by CKD stage from baseline to Week 48 following ETV-ODT conversion

Time frame
Baseline to week 48
3

Incidence of HBV recurrence

Incidence of HBV recurrence

Time frame
Baseline to week 48
4

Change in cholesterol status, proteinuria and liver stiffness

Change in cholesterol status (LDL, HDL, total cholesterol, triglycerides), proteinuria (protein-to-creatinine ratio and albumin-to-creatinine ratio), and liver stiffness by FibroScan from baseline to Week 48 following ETV-ODT conversion

Time frame
Baseline to week 48

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jongman Kim

Lead sponsor

Samsung Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: