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EFFicacy Optimization Research of Telbivudine Therapy

NCT00962533 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2013-01-31

No results posted yet for this study

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.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

telbivudine

telbivudine, 600mg, oral, daily

DRUG

telbivudine

telbivudine, 600mg, oral, daily

Sponsors & Collaborators

  • Major Science and Technology Special Project of China Eleventh Five-year

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Jinlin Hou, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-04-30
Completion
2012-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT00962533 on ClinicalTrials.gov