Trials / Completed
CompletedNCT00410072
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 669 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entecavir | Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks |
| DRUG | Entecavir + Tenofovir | Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2006-12-12
- Last updated
- 2013-03-15
- Results posted
- 2012-02-03
Locations
68 sites across 13 countries: United States, Argentina, Australia, Brazil, Canada, France, India, Italy, Mexico, Poland, Russia, South Africa, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT00410072. Inclusion in this directory is not an endorsement.