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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00410202 |
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
Condition | Intervention | Phase |
---|---|---|
Hepatitis B, Chronic |
Drug: Entecavir Drug: Adefovir + Lamivudine Drug: Entecavir + Adefovir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Subjects: The DEFINE Study |
Estimated Enrollment: | 420 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Experimental |
Drug: Entecavir
Tablets, Oral, ETV = 1mg, once daily, 100 weeks
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B1: Experimental |
Drug: Adefovir + Lamivudine
Tablets, Oral, Adefovir 10 mg + Lamivudine 100 mg, once daily, 100 weeks
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C1: Experimental |
Drug: Entecavir + Adefovir
Tablets, Oral, ETV = 1 mg + Adefovir 10 mg once daily, 100 weeks
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI463-111 |
Study First Received: | December 11, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00410202 |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Lamivudine Hepatitis Virus Diseases Digestive System Diseases |
Entecavir Hepatitis B, Chronic Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |