Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	Idenix Pharmaceuticals Novartis
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00132652

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Lamivudine Drug: Telbivudine	Phase III

MedlinePlus related topics:

Hepatitis Hepatitis B

Drug Information available for:

Lamivudine Hepatitis B Vaccines Telbivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Idenix Pharmaceuticals:

Estimated Enrollment:

240

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132652

Locations


United States, California

	San Diego, California, United States

United States, New York

	New York, New York, United States

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States

Australia

	Westmead, Australia

Canada, Ontario

	Toronto, Ontario, Canada

Canada, Quebec

	Montreal, Quebec, Canada

China

	Beijing, China

France

	Nice, France

Israel

	Tel Aviv, Israel

New Zealand

	Auckland, New Zealand

Singapore

	Singapore, Singapore

Taiwan

	Tainan, Taiwan

Thailand

	Chiang Mai, Thailand

United Kingdom

	London, United Kingdom

Sponsors and Collaborators

Idenix Pharmaceuticals

Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	NV-02B-019
First Received:	August 18, 2005
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00132652
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Hepatitis B, Chronic

Hepatitis B

Lamivudine

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-HIV Agents

Anti-Retroviral Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Hepadnaviridae Infections

Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors

Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on November 05, 2008