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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Collaborator: Novartis Pharmaceuticals
• Treatments: Lamivudine; Telbivudine

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-2.

• 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.