EFFicacy Optimization Research of Telbivudine Therapy

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• 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:

• Male or female, from 18 (inclusive) to 65 (inclusive) years of age

• HBsAg and HBeAg positive for over six months

• Patient is willing and able to comply with the study drug regimen and all other study requirements

• Patients must give written informed consent before any assessment is performed

Exclusion Criteria:

• Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit

• Patient has a history of or clinical signs/symptoms of hepatic decompensation

• Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC

• Other protocol-defined inclusion/exclusion criteria may apply