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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00410202 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | July 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Entecavir
With the option of adding Tenofovir at week 48. (This does not apply to Korea)
|
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Other Names:
Drug: Tenofovir
Tablets, Oral, 300 mg, once daily
Other Name: Viread
|
| Active Comparator: Adefovir + Lamivudine |
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Other Name: Hepsera
Drug: Lamivudine
Tablets, Oral, 100mg, once daily, 100 weeks
Other Name: Epivir
|
| Active Comparator: Entecavir + Adefovir |
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Other Names:
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Other Name: Hepsera
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 67 Study Locations| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00410202 History of Changes |
| Other Study ID Numbers: | AI463-111 |
| Study First Received: | December 11, 2006 |
| Last Updated: | January 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
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 Lamivudine Tenofovir Tenofovir disoproxil Entecavir 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 Anti-HIV Agents |