NCT03236610

Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir

Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized Open-label Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Uijeongbu St. Mary Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

Conditions

• Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Interventions

Type	Name	Description
DRUG	tenofovir monotherapy	switching to tenofovir monotherapy
DRUG	tenofovir plus entecavir combination	continuing tenofovir plus entecavir

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-06-30
• Completion: 2019-06-30
• First posted: 2017-08-02
• Last updated: 2017-08-02

Locations

1 site across 1 country: South Korea