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

NCT04202536 Phase 4 UNKNOWN

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

Details

Lead sponsor	IlDong Pharmaceutical Co Ltd
Phase	Phase 4
Status	UNKNOWN
Enrolment	152
Start date	2019-05-29
Completion	2021-10

Conditions

• Hepatitis B
• Besifovir Dipivoxil Maleate
• Tenofovir Disoproxil Fumarate

Interventions

• Besifovir Dipivoxil Maleate
• Tenofovir disoproxil fumarate(TDF)

Primary outcomes

• The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week — at the 48th week

Countries

South Korea