A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

Novartis0 sites240 target enrollmentFebruary 2005

ConditionsChronic Hepatitis B

DrugsLamivudine Telbivudine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Hepatitis B
Sponsor: Novartis
Enrollment: 240
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

December 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Documented clinical history compatible with chronic hepatitis B
•Patient has compensated liver disease
•Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months
•Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Patient is pregnant or breastfeeding
•Patient is co-infected with hepatitis C, hepatitis D or HIV
•Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months
•Other protocol-defined exclusion criteria may apply.