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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Varna, Bulgaria
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Hamburg, Germany
Start Date
March 21, 2011
Primary Completion Date
December 10, 2015
Completion Date
December 10, 2015
Last Updated
November 5, 2018
241
ACTUAL participants
telbivudine
DRUG
tenofovir disoproxil fumarate
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06671093
NCT06885710
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06263959