NCT04070079

Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

Evaluation of Intrahepatic Immune and Virological Response to Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B: an Investigator-Initiated, Cohort Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide	TAF 25mg once daily orally, for 48 weeks

Timeline

• Start date: 2019-01-29
• Primary completion: 2022-08-30
• Completion: 2022-12-31
• First posted: 2019-08-28
• Last updated: 2019-08-28

Locations

1 site across 1 country: Canada