Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Collaborator: Novartis Pharmaceuticals
• Treatments: Adefovir; Adefovir dipivoxil; Telbivudine

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.