NCT03559790

Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea

Treatment Efficacy and Safety of Tenofovir Alafenamide (TAF) Switch Therapy in Patients Who Have Been Treated With Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B: a Real Life Multicenter Cohort Study in Korea

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B. The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	tenofovir alafenamide	To evaluate of efficacy and safety in patients with TDF-TAF switch therapy

Timeline

• Start date: 2018-07-18
• Primary completion: 2020-08-01
• Completion: 2021-08-01
• First posted: 2018-06-18
• Last updated: 2019-01-30

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study