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Clinical Trial Summary

The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).


Clinical Trial Description

Investigator-initiated, phase 4 study in which recruited patients will receive, TAF 25mg once daily, for 48 weeks (Figure 1 and Table 1). The total duration of the study to End of Follow-up (EOF) will be 48 weeks. After Week 48, participants will be offered 2 years of TAF therapy. Sample collection 0, 12, 24 w was chosen to analyze immune responses based on ALT normalization rates. This mono-center study will be conducted at Toronto Centre for Liver Disease, Canada. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04070079
Study type Interventional
Source University Health Network, Toronto
Contact
Status Recruiting
Phase Phase 4
Start date January 29, 2019
Completion date December 31, 2022

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