Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study has been completed.
Information provided by:
Idenix Pharmaceuticals Identifier:
First received: August 18, 2005
Last updated: March 1, 2007
Last verified: March 2007

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Idenix Pharmaceuticals:


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

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

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Please refer to this study by its identifier: NCT00131742

Beijing, China
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

Additional Information:
No publications provided by Idenix Pharmaceuticals

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00131742     History of Changes
Other Study ID Numbers: NV-02B-015
Study First Received: August 18, 2005
Last Updated: March 1, 2007
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Additional relevant MeSH terms:
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents processed this record on October 19, 2014