A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Novartis0 sitesFebruary 2003

ConditionsChronic Hepatitis B

Drugstelbivudine or lamivudine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Hepatitis B
Sponsor: Novartis
Primary Endpoint: Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

April 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV
•Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Patient is pregnant or breastfeeding
•Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-
•Patient previously received lamivudine or an investigational anti-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.

Outcomes

Primary Outcomes

Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.

Secondary Outcomes

Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.