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

This study has been completed.

First Received on August 18, 2005. Last Updated on November 14, 2007 History of Changes

Sponsor:	Idenix Pharmaceuticals
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Lamivudine Telbivudine

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections

DNA Virus Infections
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012