NCT01341743

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Entecavir	patients will receive oral entecavir 1mg, daily for 104 weeks.
DRUG	Entecavir, Adefovir	patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
DRUG	Entecavir, Adefovir	patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2011-04-26
• Last updated: 2013-10-30

Locations

16 sites across 1 country: China