Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

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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

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Who can participate

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

Inclusion criteria

Documented clinical history compatible with chronic hepatitis B infection

Other protocol-defined inclusion criteria may apply

Exclusion criteria

Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

Other protocol-defined exclusion criteria may apply

Treatment and study plan

telbivudine

Drug

Lamivudine

Drug

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

Novartis Pharmaceuticals

Registry information

Official study title

A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Aug 19, 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