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

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Entecavir (Drug); Entecavir + Tenofovir (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

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

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare the proportions of subjects in each treatment group who achieve HBV DNA <50 IU/mL (approximately 300 copies/mL)

Secondary outcome:

To compare the proportions of subjects in each treatment group who achieve: HBV DNA <50 IU/mL (300 copies/mL)

Mean Log 10 reduction from baseline in HBV DNA by PCR

ALT Normalization (≤ 1 x upper limit of normal)

HBeAg loss

HBe seroconversion

HBs seroconversion

Frequency of adverse events, serious adverse events, and discontinuations from study drug due to adverse events or laboratory abnormalities

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Grenoble Cedex 09 38043, France; Recruiting
Site 026

Local Institution, Strasbourg 67090, France; Recruiting
Site 027

Local Institution, Paris Cedex 12 75571, France; Recruiting
Site 028

Local Institution, Paris 75014, France; Recruiting
Site 029

Local Institution, Paris Cedex 13 75013, France; Recruiting
Site 030

Local Institution, Marseille Cedex 08 13285, France; Recruiting
Site 031

Local Institution, Thessaloniki 57010, Greece; Recruiting
Site 011

Local Institution, Athens 11527, Greece; Recruiting
Site 019

Local Institution, Lucknow 226014, India; Recruiting
Site 001

Local Institution, Vellore 632004, India; Recruiting
Site 061

Local Institution, Ludhiana 141001, India; Recruiting
Site 070

Local Institution, Pisa 56124, Italy; Recruiting
Site 040

Local Institution, Brescia 25123, Italy; Recruiting
Site 041

Local Institution, Antella Firenze 50012, Italy; Recruiting
Site 042

Local Institution, Roma 00149, Italy; Recruiting
Site 071

Local Institution, Chorzow 41-500, Poland; Recruiting
Site 006

Local Institution, Lodzi 91-347, Poland; Recruiting
Site 009

Local Institution, Warszawa 01-201, Poland; Recruiting
Site 013

Local Institution, Bialystok 15-540, Poland; Recruiting
Site 017

Local Institution, Krakow 31-531, Poland; Recruiting
Site 023

Local Institution, Lublin 20-089, Poland; Recruiting
Site 025

Local Institution, St. Petersburg 191163, Russian Federation; Recruiting
Site 043

Local Institution, Moscow 115446, Russian Federation; Recruiting
Site 044

Local Institution, Moscow 117593, Russian Federation; Recruiting
Site 045

Local Institution, St. Petersburg 191167, Russian Federation; Recruiting
Site 046

Local Institution, St. Petersburg 191167, Russian Federation; Recruiting
Site 047

Local Institution, St. Petersburg 194044, Russian Federation; Recruiting
Site 048

Local Institution, St. Petersburg 190103, Russian Federation; Recruiting
Site 049

Local Institution, Smolensk 214018, Russian Federation; Recruiting
Site 050

Local Institution, Moscow 105275, Russian Federation; Recruiting
Site 051

Local Institution, Bornova Izmir 35100, Turkey; Recruiting
Site 033

Local Institution, Sihhiye Ankara 06100, Turkey; Recruiting
Site 034

Local Institution, Cebeci Ankara 06620, Turkey; Recruiting
Site 088

Local Institution, Trabzon 61080, Turkey; Recruiting
Site 092

Local Institution, Calgary, Alberta T2N 4N1, Canada; Recruiting
Site 102

Local Institution, Hyderabad, Andhra Pradesh 500082, India; Recruiting
Site 085

Local Institution, Vancouver, British Columbia V5Z 1H2, Canada; Recruiting
Site 097

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1181ACH, Argentina; Recruiting
Site 058

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1121ABE, Argentina; Recruiting
Site 059

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1282AEN, Argentina; Recruiting
Site 074

San Jose Gastroenterology, San Jose, California 95128, United States; Recruiting
Huy Ngoc Trinh, Site 036, Phone: 408-347-9001

Research And Education, Inc., San Diego, California 92115, United States; Recruiting
Tuan Nguyen, Site 054

Sergio E. Rojter, M.D., Los Angeles, California 90017, United States; Recruiting
Sergio E. Rojter, Site 096

Yale University School Of Medicine, New Haven, Connecticut 06520, United States; Recruiting
Joseph Lim, Site 056

University Of Miami, Miami, Florida 33136, United States; Recruiting
Lennox Jeffers, Site 075

Local Institution, Pretoria, Gauteng 0001, South Africa; Recruiting
Site 091

Atlanta Gastroenterology Associates, Atlanta, Georgia 30308, United States; Recruiting
Norman Gitlin, Site 053, Phone: 404-253-6882

Rubin, Raymond A., Atlanta, Georgia 30309, United States; Recruiting
Raymond A. Rubin, Site 094, Phone: 404-355-3200

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada; Recruiting
Site 101

Digestive Disease Associates, P.A., Baltimore, Maryland 21229, United States; Recruiting
Natarajan Ravendhran, Site 037

Maryland Digestive Disease Research, Laurel, Maryland 20707, United States; Recruiting
Theodore Kim, Site 104

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Daryl Tan-Yeung Lau, Site 063, Phone: 617-632-1089

University Of Michigan Health System, Ann Arbor, Michigan 48109, United States; Recruiting
Anna S. F. Lok, Site 076

Local Institution, Santa Efigenia, Minas Gerais 30150, Brazil; Recruiting
Site 082

Local Institution, Westmead Nsw, New South Wales 2145, Australia; Recruiting
Site 068

North Shore University, Manhasset, New York 11030, United States; Recruiting
David Bernstein, Site 039

Dieterich, Douglas, New York, New York 10029, United States; Recruiting
Douglas Dieterich, Site 077

Min, Albert, New York, New York 10003, United States; Recruiting
Albert Min, Site 079

Chan, Sing, Flushing, New York 11355, United States; Recruiting
Sing Chan, Site 089, Phone: 718-886-6292

Concorde Medical Group, New York, New York 10016, United States; Recruiting
Hillel Tobias, Site 105

Local Institution, Toronto, Ontario M3N 2V7, Canada; Recruiting
Site 098

Local Institution, Toronto, Ontario M5T 2S8, Canada; Recruiting
Site 099

Local Institution, Toronto, Ontario M5G 2N2, Canada; Recruiting
Site 103

Local Institution, Greenslopes Qld, Queensland 4102, Australia; Recruiting
Site 066

Local Institution, Porto Alegre Rs, Rio Grande Do Sul 90035, Brazil; Recruiting
Site 060

Local Institution, Rosario, Santa Fe S2000PBJ, Argentina; Recruiting
Site 057

Local Institution, Campinas, Sao Paulo 13083, Brazil; Recruiting
Site 086

Local Institution, Clayton Vic, Victoria 3168, Australia; Recruiting
Site 064

Local Institution, Heidelberg, Victoria 3084, Australia; Recruiting
Site 065

Local Institution, Fitzroy, Victoria 3065, Australia; Recruiting
Site 067

Local Institution, Prahan, Victoria 3004, Australia; Recruiting
Site 069

Local Institution, Bellville, Western Cape 7530, South Africa; Recruiting
Site 035

Local Institution, N1 City Goodwood, Western Cape 7463, South Africa; Recruiting
Site 038

BMS Clinical Trials Disclosure

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

Starting date: April 2007
Ending date: September 2011
Last updated: October 20, 2008