drugset / Trial / NCT03356834

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

NCT03356834

Phase 4 Completed 575 enrolled Humanity and Health Research Centre
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-12-01
Primary completion
2024-10-31
Completion
2024-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tenofovir disoproxil fumarate Small molecule 300 mg Oral
Subject tenofovir alafenamide Small molecule 25 mg Oral