An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto, Canada

Who can participate

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

Inclusion criteria

Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
Patient remains seropositive for hepatitis B surface antigen (HBsAg)

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Patient is pregnant or breast-feeding
Patient has signs of decompensated chronic hepatitis B

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 IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003

Important dates

Primary completion: 2003
Study completion: 2005
First posted: Jul 27, 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