NCT00962533

EFFicacy Optimization Research of Telbivudine Therapy

A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	telbivudine	telbivudine, 600mg, oral, daily
DRUG	telbivudine	telbivudine, 600mg, oral, daily

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2009-08-20
• Last updated: 2013-01-31

Locations

24 sites across 1 country: China