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Sponsored by: |
Bristol-Myers Squibb |
---|---|
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: Tenofovir Drug: Adefovir Drug: Lamivudine |
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: | May 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Entecavir: Active Comparator
(with the option of adding Tenofovir at week 48)
|
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Drug: Tenofovir
Tablets, Oral, 300 mg, once daily
|
Adefovir + Lamivudine: Active Comparator |
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Drug: Lamivudine
Tablets, Oral, 100mg, once daily, 100 weeks
|
Entecavir + Adefovir: Active Comparator |
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
|
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: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00410202 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Anti-HIV Agents Hepatitis, Chronic Hepatitis, Viral, Human Lamivudine Antiviral Agents Reverse Transcriptase Inhibitors Hepatitis Virus Diseases Entecavir |
Digestive System Diseases Anti-Retroviral Agents Hepatitis B, Chronic Hepatitis B Tenofovir DNA Virus Infections Adefovir dipivoxil Adefovir Tenofovir disoproxil |
Anti-Infective Agents Liver Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Hepatitis, Viral, Human Lamivudine Enzyme Inhibitors Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions Reverse Transcriptase Inhibitors |
Hepatitis Virus Diseases Entecavir Digestive System Diseases Anti-Retroviral Agents Therapeutic Uses Hepatitis B, Chronic Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir Nucleic Acid Synthesis Inhibitors |