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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
Novartis Pharmaceuticals
Information provided by:

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

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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

Primary Outcome Measures :
  1. 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 :
  1. Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.

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

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.

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

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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
Barcelona, Spain
Valencia, Spain
Bangkok, Thailand
Istanbul, Turkey
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
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