Status:
COMPLETED
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Evidence of decompensated cirrhosis
- Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- Laboratory values out of protocol-specified range
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
669 Patients enrolled
Trial Details
Trial ID
NCT00410072
Start Date
April 1 2007
End Date
October 1 2010
Last Update
March 15 2013
Active Locations (68)
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1
Sergio E. Rojter
Los Angeles, California, United States, 90017
2
Tuan Nguyen, Md
San Diego, California, United States, 92105
3
San Jose Gastroenterology
San Jose, California, United States, 95128
4
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510