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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00131742
First received: August 18, 2005
Last updated: March 1, 2007
Last verified: March 2007
History of Changes
  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 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:

U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

  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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Idenix Pharmaceuticals

Additional 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
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
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
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

ClinicalTrials.gov processed this record on May 22, 2013