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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00115245

Enrollment

Unknown

Registered

2005-06-22

Start date

2004-11-30

Completion date

2006-08-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

DRUGTelbivudine (LdT)

DRUGAdefovir Dipivoxil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Countries

Australia, Canada, China, France, Singapore, South Korea, Taiwan, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026