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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis B | Drug: Telbivudine (LdT) Drug: Adefovir Dipivoxil | Phase 3 |
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 |


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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.

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
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 |
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 |
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 |