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

PHASE3CompletedINTERVENTIONAL
Enrollment

669

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Hepatitis B, Chronic
Interventions
DRUG

Entecavir

Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks

DRUG

Entecavir + Tenofovir

Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks

Trial Locations (68)

2145

Local Institution, Westmead Nsw

3004

Local Institution, Prahan

3065

Local Institution, Fitzroy

3084

Local Institution, Heidelberg

3168

Local Institution, Clayton Vic

7463

Local Institution, N1 City Goodwood

7530

Local Institution, Bellville

10003

Beth Israel Medical Center, New York

10016

Concorde Medical Group, New York

10029

Mount Sinai School Of Medicine, New York

11030

North Shore University, Manhasset

11355

Sing Chan, Md, Flushing

13285

Local Institution, Marseille

20707

Maryland Digestive Disease Research, Llc, Laurel

21229

Digestive Disease Associates, P.A., Baltimore

25123

Local Institution, Brescia

30150

Local Institution, Belo Horizonte

30308

Atlanta Gastroenterology Associates, Atlanta

30309

Digestive Healthcare Of Georgia, Atlanta

33136

University Of Miami, Miami

34229

Local Institution, Durango

35100

Local Institution, Bornova Izmir

38043

Local Institution, Grenoble

48109

University Of Michigan Health System, Ann Arbor

50012

Local Institution, Antella Firenze

56124

Local Institution, Pisa

61080

Local Institution, Trabzon

67090

Local Institution, Strasbourg

75013

Local Institution, Paris

75014

Local Institution, Paris

75571

Local Institution, Paris

90017

Sergio E. Rojter, Los Angeles

90035

Local Institution, Porto Alegre Rs

92105

Tuan Nguyen, Md, San Diego

95128

San Jose Gastroenterology, San Jose

105275

Local Institution, Moscow

115446

Local Institution, Moscow

117593

Local Institution, Moscow

141001

Local Institution, Ludhiana

190103

Local Institution, Saint Petersburg

191163

Local Institution, Saint Petersburg

191167

Local Institution, Saint Petersburg

194044

Local Institution, Saint Petersburg

214018

Local Institution, Smolensk

226014

Local Institution, Lucknow

500082

Local Institution, Hyderabad

632004

Local Institution, Vellore

06510

Yale University School Of Medicine, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

C1121ABE

Local Institution, Ciudad de Buenos Aires

C1181ACH

Local Institution, Ciudad de Buenos Aires

C1282AEN

Local Institution, Ciudad de Buenos Aires

S2000PBJ

Local Institution, Rosario

T2N 4Z6

Local Institution, Calgary

V5Z 1H2

Local Institution, Vancouver

R3E 3P4

Local Institution, Winnipeg

M3N 2V7

Local Institution, Toronto

M5G 2N2

Local Institution, Toronto

M5T 2S8

Local Institution, Toronto

00149

Local Institution, Roma

15-540

Local Institution, Bialystok

41-500

Local Institution, Chorzów

31-531

Local Institution, Krakow

20-081

Local Institution, Lublin

01-201

Local Institution, Warsaw

0001

Local Institution, Pretoria

06620

Local Institution, Cebeci Ankara

06100

Local Institution, Sihhiye Ankara

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY