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

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ClinicalTrials.gov Identifier: NCT00057265

Recruitment Status : Completed

First Posted : March 31, 2003

Last Update Posted : March 20, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Novartis Pharmaceuticals

Information provided by:

Novartis

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Hepatitis B	Drug: telbivudine or lamivudine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
Study Start Date :	February 2003
Actual Primary Completion Date :	April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Telbivudine Lamivudine

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years to 70 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057265

Locations

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United States, California

Los Angeles, California, United States

Orange, California, United States

San Diego, 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

Novartis

Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1016/j.jhep.2008.12.019. 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. doi: 10.1056/NEJMoa066422.

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ClinicalTrials.gov Identifier:	NCT00057265
Other Study ID Numbers:	NV-02B-007
First Posted:	March 31, 2003 Key Record Dates
Last Update Posted:	March 20, 2015
Last Verified:	March 2015

Additional relevant MeSH terms:

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Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections	Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Lamivudine Telbivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents

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