Overview

A Two-year Study of Telbivudine in HBeAg Negative Hepatitis

Status:
Completed
Trial end date:
2014-05-30
Target enrollment:
Participant gender:
Summary
Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time points according to individual patient response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year efficacy, but we still look forward to more efficient treatment and lower resistance rate. This study complies with the principle of individualized therapy recommended and ethical principles. It is expected that this study design with individualized treatment approach may improve efficacy and lower the resistance rates. In addition, it will provide important information on how to bring greater benefits to patients with CHB.
Phase:
Phase 4
Details
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators:
Guangdong Provincial People's Hospital
Guangzhou 8th People's Hospital
Treatments:
Adefovir
Adefovir dipivoxil
Telbivudine