Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
NCT ID: NCT00410072
Last Updated: 2013-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
669 participants
INTERVENTIONAL
2007-04-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TDF 0.5 mg
TDF=tenofovir
Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Interventions
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Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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\*10\*5\*IU/mL (approximately 10\*6\*copies/mL) for HbeAg-positive participants
* HBV DNA \>1.72\*10\*4\*IU/mL (approximately 10\*5\*copies/mL) for Hbe-Ag-negative participants
* Alanine aminotransferase level ≥\*upper limit of normal (ULN) and ≤10\*ULN
Exclusion Criteria
* Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* Laboratory values out of protocol-specified range
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Sergio E. Rojter
Los Angeles, California, United States
Tuan Nguyen, Md
San Diego, California, United States
San Jose Gastroenterology
San Jose, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
University Of Miami
Miami, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Digestive Healthcare Of Georgia
Atlanta, Georgia, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Maryland Digestive Disease Research, Llc
Laurel, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Sing Chan, Md
Flushing, New York, United States
North Shore University
Manhasset, New York, United States
Beth Israel Medical Center
New York, New York, United States
Concorde Medical Group
New York, New York, United States
Mount Sinai School Of Medicine
New York, New York, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Rosario, Prov de Santa, Argentina
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Westmead Nsw, New South Wales, Australia
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Clayton Vic, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Prahan, Victoria, Australia
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre Rs, Rio Grande do Sul, Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Grenoble, , France
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Marseille, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Strasbourg, , France
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Hyderabad, Andhra Pradesh, India
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Lucknow, , India
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Ludhiana, , India
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Vellore, , India
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Antella Firenze, , Italy
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Brescia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Durango, Durango, Mexico
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Bialystok, , Poland
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Chorzów, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Pretoria, Gauteng, South Africa
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Bellville, Western Cape, South Africa
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N1 City Goodwood, Western Cape, South Africa
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Bornova Izmir, , Turkey (Türkiye)
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Cebeci Ankara, , Turkey (Türkiye)
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Sihhiye Ankara, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
Countries
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References
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Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, Sievert W, Wong D, Lovegren M, Cohen D, Llamoso C. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):619-628.e1. doi: 10.1053/j.gastro.2012.05.037. Epub 2012 May 27.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-110
Identifier Type: -
Identifier Source: org_study_id
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