At a glance
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OPTIMA: A Randomized, Open-label, 156-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
In Brief
A Phase 4 clinical trial evaluating telbivudine and tenofovir disoproxil fumarate for Chronic Hepatitis B. Completed, enrolled 241 participants across 34 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.
Study Details
Timeline
Interventions
600 mg film-coated tablets taken as 600 mg once daily
300 mg tablets taken as 300 mg once daily