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

This study has been completed.

First Received: March 28, 2003 Last Updated: November 14, 2007 History of Changes

Sponsor:	Idenix Pharmaceuticals
Collaborator:	Novartis
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00057265

Purpose

This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: telbivudine or lamivudine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Lamivudine Telbivudine

U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:

Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.

Secondary Outcome Measures:

Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.

Study Start Date:

February 2003

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV

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), HIV-1 or HIV-2.
Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time
Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

Other protocol defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057265

Locations

United States, California

San Diego, California, United States

Los Angeles, California, United States

Orange, California, United States
United States, New Jersey

Hackensack, New Jersey, United States
United States, Texas

Houston, Texas, United States
Korea, Republic of

Seoul, Korea, Republic of
Spain

Barcelona, Spain

Valencia, Spain
Thailand

Bangkok, Thailand
Turkey

Istanbul, Turkey
United Kingdom

London, United Kingdom

Sponsors and Collaborators

Idenix Pharmaceuticals

Novartis

More Information

Additional Information:

Idenix Pharmaceuticals, Inc. web page This link exits the ClinicalTrials.gov site

No publications provided by Idenix Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Zeuzem S, Gane E, Liaw YF, Lim SG, DiBisceglie A, Buti M, Chutaputti A, Rasenack J, Hou J, O'Brien C, Nguyen TT, Jia J, Poynard T, Belanger B, Bao W, Naoumov NV. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J Hepatol. 2009 Jul;51(1):11-20. Epub 2009 Feb 12.

Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, Chen Y, Heathcote EJ, Rasenack J, Bzowej N, Naoumov NV, Di Bisceglie AM, Zeuzem S, Moon YM, Goodman Z, Chao G, Constance BF, Brown NA; Globe Study Group. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007 Dec 20;357(25):2576-88.

Study ID Numbers:	NV-02B-007
Study First Received:	March 28, 2003
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00057265 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Lamivudine
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009