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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00115245
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
Criteria

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.

Contacts and Locations
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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


Locations
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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
Australia
Clayton, Australia
Wooloongabba, Australia
Canada
Calgary, Canada
Toronto, Canada
Winnipeg, Canada
China
Hong Kong, China
France
Paris, France
Korea, Republic of
Seoul, Korea, Republic of
Singapore
Singapore, Singapore
Taiwan
Taipei, Taiwan
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Novartis
Novartis Pharmaceuticals
More Information
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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
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Adefovir
Adefovir dipivoxil
Telbivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action