NCT04202536

Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate

A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretreated With TDF

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B

Conditions

• Hepatitis B
• Besifovir Dipivoxil Maleate
• Tenofovir Disoproxil Fumarate

Interventions

Type	Name	Description
DRUG	Besifovir Dipivoxil Maleate	Besifovir 150 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d. Other Name: Besifovir®
DRUG	Tenofovir disoproxil fumarate(TDF)	300 mg tablet administered orally once daily Other Name: VIREAD®

Timeline

• Start date: 2019-05-29
• Primary completion: 2021-06-01
• Completion: 2021-10-01
• First posted: 2019-12-17
• Last updated: 2019-12-17

Locations

1 site across 1 country: South Korea