Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials. The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND

• On TAF 25 mg daily as antiviral treatment for CHB (cases); OR

• On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)

Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
Shatin
Time Frame
Start Date: 2022-09-01
Completion Date: 2026-12-31
Participants
Target number of participants: 1800
Treatments
TAF-treated Chronic hepatitis B patients
Chronic hepatitis B patients that treated with Tenofovir alafenamide
ETV-treated Chronic hepatitis B patients
Chronic hepatitis B patients that treated with Entecavir
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov