Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00410072

Purpose

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

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: Entecavir Drug: Entecavir + Tenofovir	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Entecavir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	384
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Entecavir Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
B2: Experimental	Drug: Entecavir + Tenofovir Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410072

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Locations

United States, California
San Jose Gastroenterology
San Jose, California, United States, 95128
Dr. Nguyen Tuan, Md
San Diego, California, United States, 92105
St. Vincent Hospital
Los Angeles, California, United States, 90017
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
University Of Miami
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
Digestive Healthcare Of Georgia
Atlanta, Georgia, United States, 30309
United States, Maryland
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
Maryland Digestive Disease Research
Laurel, Maryland, United States, 20707
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New York
North Shore University
Manhasset, New York, United States, 11030
Mount Sinai School Of Medicine
New York, New York, United States, 10029
Beth Israel Medical Center
New York, New York, United States, 10003
Office Of Dr. Sing Chan
Flushing, New York, United States, 11355
Argentina, Buenos Aires
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1181ACH
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1121ABE
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1282AEN
Argentina, Prov De Santa
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Rosario, Prov De Santa, Argentina, S2000PBJ
Australia, New South Wales
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Westmead Nsw, New South Wales, Australia, 2145
Australia, Victoria
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Prahan, Victoria, Australia, 3004
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Heidelberg, Victoria, Australia, 3084
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Fitzroy, Victoria, Australia, 3065
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Clayton Vic, Victoria, Australia, 3168
Brazil, Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150
Brazil, Rio Grande Do Sul
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Porto Alegre Rs, Rio Grande Do Sul, Brazil, 90035
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 1H2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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Toronto, Ontario, Canada, M3N 2V7
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Toronto, Ontario, Canada, M5T 2S8
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Toronto, Ontario, Canada, M5G 2N2
France
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Grenoble Cedex 09, France, 38043
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Strasbourg, France, 67090
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Paris Cedex 12, France, 75571
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Paris Cedex 13, France, 75013
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Marseille Cedex 08, France, 13285
India
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Lucknow, India, 226014
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Vellore, India, 632004
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Ludhiana, India, 141001
India, Andhra Pradesh
Local Institution
Hyderabad, Andhra Pradesh, India, 500082
Italy
Local Institution
Pisa, Italy, 56124
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Brescia, Italy, 25123
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Antella Firenze, Italy, 50012
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Roma, Italy, 00149
Poland
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Chorzow, Poland, 41-500
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Warszawa, Poland, 01-201
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Bialystok, Poland, 15-540
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Krakow, Poland, 31-531
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Lublin, Poland, 20-081
Russian Federation
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St. Petersburg, Russian Federation, 191163
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Moscow, Russian Federation, 115446
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St. Petersburg, Russian Federation, 194044
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St. Petersburg, Russian Federation, 191167
Local Institution
St. Petersburg, Russian Federation, 191167
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Moscow, Russian Federation, 117593
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St. Petersburg, Russian Federation, 190103
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Smolensk, Russian Federation, 214018
Local Institution
Moscow, Russian Federation, 105275
South Africa, Western Cape
Local Institution
Bellville, Western Cape, South Africa, 7530
Local Institution
N1 City Goodwood, Western Cape, South Africa, 7463
Turkey
Local Institution
Bornova Izmir, Turkey, 35100
Local Institution
Sihhiye Ankara, Turkey, 06100
Local Institution
Cebeci Ankara, Turkey, 06620

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI463-110
Study First Received:	December 11, 2006
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00410072 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis

Virus Diseases
Digestive System Diseases
Entecavir
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
Tenofovir
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on November 27, 2009