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NCT03356834CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 26 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
575 (actual)
First submitted
20 Sept 2017
Start date
1 Dec 2017
Primary completion date
31 Oct 2024
Lead sponsor
Humanity and Health Research Centre
Diseases
Hepatitis B
NCT number
NCT03356834

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 575
  • From 1 Dec 2017 to the primary completion date, 31 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • Diagnosis of HCC

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Humanity and Health GI and Liver Centre
Coordinator of this site? Confirm its status
Hong KongHong KongUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.