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

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ClinicalTrials.gov Identifier: NCT00115245
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : May 12, 2015
Novartis Pharmaceuticals
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Telbivudine (LdT) Drug: Adefovir Dipivoxil Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

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): NCT00115245

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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00115245    
Other Study ID Numbers: NV-02B-018
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action