A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen
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ClinicalTrials.gov Identifier: NCT00035789 |
Recruitment Status
:
Completed
First Posted
: May 6, 2002
Last Update Posted
: April 14, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis B | Drug: Entecavir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Study Start Date : | November 2001 |
Actual Primary Completion Date : | May 2005 |
Actual Study Completion Date : | May 2005 |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;
- HBeAg negative, anti-HBeAb positive;
- Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
- Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
- Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)

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): NCT00035789

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00035789 History of Changes |
Other Study ID Numbers: |
AI463-027 |
First Posted: | May 6, 2002 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | January 2010 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B 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 Entecavir Antiviral Agents Anti-Infective Agents |