Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection

NCT05410496 · tracked via the Priya Life Science China tracker

Sponsor

Taichung Veterans General Hospital

Phase

Phase 4

Started

2021-06-22

Last updated

2026-05-04

Condition(s) studied

Safety IssuesChronic Hepatitis BTransplant Recipient

Investigational drug(s) / intervention(s)

Tenofovir Alafenamide 25 MG

Tenofovir Alafenamide 25 MG: To assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.

Study summary

tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with chronic HBV infection. The aim of this prospective cohort study is to assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. At least 20 years of age 2. Chronic HBV infection under NA therapy other than TAF 3. Underwent kidney and/ or liver transplantation 4. Without clinical or pathologic evidence of moderate or severe rejection 5. Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs. Exclusion Criteria: 1. End stage renal disease (eGFR \< 15 mL/min/1.73m2) 2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) 3. Any active malignancies 4. Pregnant or breast-feeding women 5. Known allergy to tenofovir-contained regimens

Primary outcome measure(s)

Estimated glomerular filtration rate — week 48
0-120 ml/min/1.73m2 (higher scores mean a better outcome)
HBV viral load — week 48
0-8 log10 IU/mL; blood HBV DNA level (higher scores mean a worse outcome)
Drug adherence score — week 48 (higher scores mean a better outcome)
Score 1-8; Morisky Medication Adherence Scale-8 questionnaire

Trial sites (2)

Facility	City	Region	Status
Taichung Veterans General Hospital	Taichung	Taiwan
China Medical University Hospital	Taichung	Taiwan

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Other trials for the same condition

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A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B Active, not recruiting

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) Active, not recruiting

Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever Recruiting

The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05410496 on ClinicalTrials.gov ↗ ← All trials in China