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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00115245
First received: June 21, 2005
Last updated: March 1, 2007
Last verified: March 2007
  Purpose

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 Idenix Pharmaceuticals:

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115245

Locations
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
Idenix Pharmaceuticals
Novartis
  More Information

Additional Information:
No publications provided by Idenix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00115245     History of Changes
Other Study ID Numbers: NV-02B-018
Study First Received: June 21, 2005
Last Updated: March 1, 2007
Health Authority: United States: 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
Adefovir
Adefovir dipivoxil
Telbivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 28, 2014