Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

Completed · Phase 3

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT00410072

Run by

Bristol-Myers Squibb

People needed

669

Starts

2007-04-01

Expected to finish

2010-10-01

Last updated by the study team

2013-03-15

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [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*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

You may not qualify if…

• Evidence of decompensated cirrhosis
• Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
• Laboratory values out of protocol-specified range

Where it is running

• 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
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Rosario, Prov de Santa, Argentina
• Local Institution — Westmead Nsw, New South Wales, Australia
• Local Institution — Clayton Vic, Victoria, Australia
• Local Institution — Fitzroy, Victoria, Australia
• Local Institution — Heidelberg, Victoria, Australia
• Local Institution — Prahan, Victoria, Australia
• Sergio E. Rojter — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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