Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

This study has been completed.
Novartis Pharmaceuticals
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Novartis Identifier:
First received: June 21, 2005
Last updated: May 8, 2015
Last verified: May 2015
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

Condition Intervention Phase
Chronic Hepatitis B
Drug: Telbivudine (LdT)
Drug: Adefovir Dipivoxil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Resource links provided by NLM:

Further study details as provided by Novartis:

Study Start Date: November 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
  • Detectable serum HBsAg at the Screening visit

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding.
  • Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
  • Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (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.

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Please refer to this study by its identifier: NCT00115245

United States, California
Los Angeles, California, United States
Pasadena, California, United States
San Francisco, California, United States
United States, Florida
Miami, Florida, United States
Clayton, Australia
Wooloongabba, Australia
Calgary, Canada
Toronto, Canada
Winnipeg, Canada
Hong Kong, China
Paris, France
Korea, Republic of
Seoul, Korea, Republic of
Singapore, Singapore
Taipei, Taiwan
Bangkok, Thailand
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00115245     History of Changes
Other Study ID Numbers: NV-02B-018
Study First Received: June 21, 2005
Last Updated: May 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Adefovir dipivoxil
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on November 30, 2015