A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Novartis0 sitesNovember 2004

ConditionsChronic Hepatitis B

DrugsTelbivudine (LdT)Adefovir Dipivoxil

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Hepatitis B
Sponsor: Novartis
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

August 2006

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
•Detectable serum HBsAg at the Screening visit
•Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Patient is pregnant or breastfeeding.
•Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
•Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
•Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
•Other protocol-defined exclusion criteria may apply.