Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Chronic Hepatitis B
Interventions
DRUG

Tenofovir disoproxil fumarate (tenofovir DF; TDF)

300-mg tablet QD

DRUG

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD

DRUG

Entecavir (ETV)

0.5-mg or 1-mg tablet QD

DRUG

TDF placebo

Placebo to match TDF QD

DRUG

FTC/TDF placebo

Placebo to match FTC/TDF QD

DRUG

ETV placebo

Placebo to match ETV QD

Trial Locations (38)

114

Chang-Gung Memorial Hospital, Taipei

833

Chang Gung Memorial Hospital - Kaohsiung, Kaoshiung Hsien

10029

Mt. Sinai School of Medicine/ Mt. Sinai Medical Center, New York

10032

Columbia Presbyterian Medical Center, New York

10650

Cathay General Hospital, Taipei

11527

"General Hospital of Athens Ippokratio", Athens

13005

Hopital Conception, Marseille

13353

Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie, Berlin

22031

Metropolitan Research, Fairfax

28007

Hospital General Universitario Gregorio Maranon, Madrid

33100

Policlinico Universitario, Udine

33136

University of Miami, Center for Liver Diseases, Miami

34899

Marmara Universitesi School of Medicine, Istanbul

35100

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

35128

Universita de Padova, Padua

46026

Hospital Universitario y Politecnico la Fe, Valencia

48202

Henry Ford Hospital and Health System, Detroit

55131

Johannes Gutenberg-Universitat, Mainz

60612

Rush Presbyterian - St. Luke's Medical Center, Chicago

69120

Universitat Heidelberg, Heidelberg

70428

National Cheng Kung University Hospital, Tainan City

90095

Pfleger Liver Institute, Los Angeles

94115

California Pacific Medical Center Research Institute, San Francisco

98104

Virginia Mason Medical Center, Seattle

119074

National University Hospital Dept. of Gastroenterology & Hepatology, Singapore

169608

Singapore General Hospital, Singapore

308433

Tan Tock Seng Hospital, Singapore

529889

Changi General Hospital, Singapore

T2N4N1

Heritage Medical Research Clinic, Calgary

V5Z1H2

Vancouver General Hospital, Vancouver

V5Z3M9

The Gordon & Leslie Diamond Centre, Vancouver

M5G 2C4

Toronto General Hospital, Toronto

15-540

Wojewodzki Szpital Specjalistyczny im Dluskeigo, Bialystok

85-030

Wojewodzki Szpital Obserwacy, Bydgoszcz

01-201

Wojewodzki Szpital Zakazny, Warsaw

08035

Hospital General Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona (HCPB), Barcelona

08907

Hospital Universitario de Bellvitge, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY