Skip to main content
OpenTrials
Completed

NCT Number: NCT03356834

Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Humanity and Health GI and Liver Centre

Hong Kong, 00852

About this study

Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic hepatitis B,
  • Antiviral experienced,
  • Currently on long term TDF anti-HBV treatment,
  • HBV DNA < 6 log IU/ml (LLOD)
  • Able to sign the consent form of anticipating in the study

Exclusion criteria

  • Co-infected with HCV, HIV or other viral hepatitis,
  • Diagnosis of HCC

Treatment and study plan

Tenofovir alafenamide(TAF)

Drug

25 mg tablet administered orally once daily

Other names: VEMLIDY®

Tenofovir disoproxil fumarate(TDF)

Drug

300 mg tablet administered orally once daily

Other names: VIREAD®

Primary outcomes

  1. Antiviral response of TAF

    Time frame: 60 months

    Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients

Secondary outcomes

  1. Improvement of renal function and bone mineral density in CHB patients switching to TAF

    Time frame: 60 months

    Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Registry information

Official study title

Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF

Acronym: SWITAF

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2017
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.