CompletedPhase 4

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

Hong Kong575 participantsStarted 2017-12-01

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Antiviral response of TAF

Timeframe: 60 months

Trial details

NCT IDNCT03356834

SponsorHumanity and Health Research Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Chronic Hepatitis B trials