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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00131742
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Study Start Date : July 2004
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Documented clinical history compatible with chronic hepatitis B infection

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) or HIV
  • Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

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): NCT00131742


Locations
China
Beijing, China
Sponsors and Collaborators
Novartis
Novartis Pharmaceuticals
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131742     History of Changes
Other Study ID Numbers: NV-02B-015
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents