EFFORT Extension Study

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

• To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Major Science and Technology Special Project of China Eleventh Five-year; Novartis
• Treatments: Telbivudine

Criteria

Inclusion Criteria:

• Treated with telbivudine or combined with adefovir in EFFORT study

• Patients are willing to participate in the extension study

• Patients provide information consent form

Exclusion Criteria:

• Adjustment of poor compliance by investigators