| December 11, 2006 |
| November 16, 2009 |
| April 2007 |
| October 2010 (final data collection date for primary outcome measure) |
| To compare the proportions of subjects in each treatment group who achieve HBV DNA <50 IU/mL (approximately 300 copies/mL) [ Time Frame: at Week 96 ] [ Designated as safety issue: No ] |
| To compare the proportions of subjects in each treatment group who achieve HBV DNA <50 IU/mL (approximately 300 copies/mL) at Week 96 |
| Complete list of historical versions of study NCT00410072 on ClinicalTrials.gov Archive Site |
- To compare the proportions of subjects in each treatment group who achieve: HBV DNA <50 IU/mL (300 copies/mL) [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
- Mean Log 10 reduction from baseline in HBV DNA by PCR [ Time Frame: at Weeks 48 and 96 ] [ Designated as safety issue: No ]
- ALT Normalization (≤ 1 x upper limit of normal) [ Time Frame: at Weeks 48 and 96 ] [ Designated as safety issue: No ]
- HBeAg loss [ Time Frame: at Weeks 48 and 96 ] [ Designated as safety issue: No ]
- HBe seroconversion [ Time Frame: at Weeks 48 and 96 ] [ Designated as safety issue: No ]
- HBs seroconversion [ Time Frame: at Weeks 48 and 96 ] [ Designated as safety issue: No ]
- Frequency of adverse events, serious adverse events, and discontinuations from study drug due to adverse events or laboratory abnormalities [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]
|
- To compare the proportions of subjects in each treatment group who achieve
- HBV DNA <50 IU/mL (300 copies/mL) at Week 48
- Mean Log 10 reduction from baseline in HBV DNA by PCR at Weeks 48 and 96
- ALT Normalization (≤ 1 x upper limit of normal) at Weeks 48 and 96
- HBeAg loss at Weeks 48 and 96
- HBe seroconversion at Weeks 48 and 96
- HBs seroconversion at Weeks 48 and 96
- Frequency of adverse events, serious adverse events, and discontinuations from study drug due to adverse events or laboratory abnormalities
|
| |
| 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 |
The purpose of this study is to evaluate the effectiveness of entecavir plus tenofovir combination therapy compared with entecavir monotherapy. Safety will also be studied |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Hepatitis B, Chronic |
- Drug: Entecavir
- Drug: Entecavir + Tenofovir
|
| |
| |
| |
| Active, not recruiting |
| 384 |
| April 2011 |
| October 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Chronic HBV infection (HbeAg-positive or negative) disease
- Nucleoside- and nucleotide-naive
- Males or females ≥16 years of age (or minimum age of consent in a given country)
- Compensated liver function
- HBV DNA >1.72 x 10*5* IU/mL (approximately 10*6* copies/mL) for HbeAg-positive subjects
- HBV DNA >1.72 x 10*4* IU/mL (approximately 10*5* copies/mL) for Hbe-Ag-negative subjects
- ALT ≥ x upper limit of normal and ≤ 10 x upper limit of normal
Exclusion Criteria:
- Evidence of decompensated cirrhosis
- Coinfection with HIV, HCV, or HDV
- Laboratory values out of protocol-specified range
|
| Both |
| 16 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Australia, Brazil, Canada, France, India, Italy, Poland, Russian Federation, South Africa, Turkey |
| |
| NCT00410072 |
| Study Director, Bristol-Myers Squibb |
| AI463-110 |
| Bristol-Myers Squibb |
|
| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
|
|
| Bristol-Myers Squibb |
| January 2009 |
