NCT03933384

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Detailed description

With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).

Conditions

• Hepatitis B
• Viral Hepatitis

Interventions

Type	Name	Description
DRUG	Tenofovir alafenamide	Tenofovir alafenamide 25mg/tab once daily
DRUG	Entecavir	Entecavir 0.5mg/tab once daily

Timeline

• Start date: 2019-08-19
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2019-05-01
• Last updated: 2025-01-09

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study