NCT03236584

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• 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 lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir 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	lamivudine plus adefovir combination	continuing lamivudine plus adefovir
DRUG	Tenofovir Disoproxil Fumarate	switching to tenofovir

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-30
• Completion: 2019-03-30
• First posted: 2017-08-02
• Last updated: 2017-08-02