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

Novartis

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis B

Treatments

Drug: Telbivudine (LdT)

Drug: Adefovir Dipivoxil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00115245

NV-02B-018

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.