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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
This study has been completed.
Sponsors and Collaborators: Idenix Pharmaceuticals
Novartis
Information provided by: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00131742
  Purpose

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


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

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Lamivudine Hepatitis B Vaccines Telbivudine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131742

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

Related Info  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, Wang Y, Zhu L, He Y, Ren H, Wan M, Chen C, Wu S, Chen Y, Xu J, Wang Q, Wei L, Chao G, Constance BF, Harb G, Brown NA, Jia J. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54.

Study ID Numbers: NV-02B-015
Study First Received: August 18, 2005
Last Updated: March 1, 2007
ClinicalTrials.gov Identifier: NCT00131742  
Health Authority: United States: Food and Drug Administration;   China: State Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
 Hepatitis B, Chronic
Hepatitis B
Lamivudine
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
 Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009



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