NCT01005238

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

A Randomized Open Label Study Evaluating the Efficacy of Continuous Telbivudine Versus Lamivudine in Patients With HBeAg-negative Chronic Hepatitis B Who Had Previously Achieved an Undetectable Viral Load During 24 Weeks of Telbivudine Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Lamivudine
DRUG	Telbivudine

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-12-01
• First posted: 2009-10-30
• Last updated: 2015-03-10

Locations

1 site across 1 country: Switzerland