Trials / Completed
CompletedNCT00410202
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 629 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entecavir | Tablets, Oral, 1mg, once daily, 100 weeks |
| DRUG | Tenofovir | Tablets, Oral, 300 mg, once daily |
| DRUG | Adefovir | Tablets, Oral, 10mg, once daily, 100 weeks |
| DRUG | Lamivudine | Tablets, Oral, 100mg, once daily, 100 weeks |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2011-01-01
- Completion
- 2012-07-01
- First posted
- 2006-12-12
- Last updated
- 2013-11-21
- Results posted
- 2012-07-04
Locations
67 sites across 18 countries: United States, Australia, Brazil, Canada, Greece, Hong Kong, India, Indonesia, Italy, Malaysia, Philippines, Poland, Russia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT00410202. Inclusion in this directory is not an endorsement.