Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
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- STATUS
- Recruiting
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- End date
- Oct 8, 2023
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- participants needed
- 1000
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- sponsor
- Humanity and Health Research Centre
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.
Description
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.
Details
| Condition | chronic hepatitis b, Hepatitis B |
|---|---|
| Treatment | Tenofovir alafenamide(TAF), Tenofovir disoproxil fumarate(TDF) |
| Clinical Study Identifier | NCT03356834 |
| Sponsor | Humanity and Health Research Centre |
| Last Modified on | 8 September 2021 |
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