NCT04034368

A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir

A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).

Conditions

• HBV

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide (TAF)	Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks；

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-07-26
• Last updated: 2019-07-26

Regulatory

• FDA-regulated drug study