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Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

NCT01379508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2018-11-05

Study results available
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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.

Conditions

Interventions

DRUG

telbivudine

600 mg film-coated tablets taken as 600 mg once daily

DRUG

tenofovir disoproxil fumarate

300 mg tablets taken as 300 mg once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-21
Primary Completion
2015-12-10
Completion
2015-12-10

Countries

  • Austria
  • Bulgaria
  • Germany
  • Greece
  • Italy
  • Russia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379508 on ClinicalTrials.gov