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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clayton, Australia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telbivudine (LdT)

Drug

Adefovir dipivoxil

Drug

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Jun 22, 2005
Registry last updated: May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed