Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine

NCT01005238 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-03-10

No results posted yet for this study

Summary

The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.

Conditions

  • Hepatitis, Chronic

Interventions

DRUG

Lamivudine

DRUG

Telbivudine

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Markus Heim, Prof. · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-12-31

Countries

  • Switzerland

Study Locations

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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 NCT01005238 on ClinicalTrials.gov