Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

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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

Westmead, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Documented clinical history compatible with chronic hepatitis B
Patient has compensated liver disease
Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis C, hepatitis D or HIV
Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lamivudine

Drug

telbivudine

Drug

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

Novartis Pharmaceuticals

Registry information

Official study title

A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Aug 22, 2005
Registry last updated: Feb 23, 2017

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