Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

PHASE3CompletedINTERVENTIONAL
Enrollment

875

Participants

Timeline

Start Date

September 11, 2013

Primary Completion Date

November 16, 2015

Study Completion Date

October 13, 2022

Conditions
HBeAg-positive Chronic Hepatitis B
Interventions
DRUG

TAF

25 mg tablet administered orally once daily

DRUG

TDF

300 mg tablet administered orally once daily

DRUG

TAF Placebo

Tablet administered orally once daily

DRUG

TDF Placebo

Tablet administered orally once daily

Trial Locations (160)

220

Far-Eastern Memorial Hospital, Taipei

404

China Medical University Hospital, Taichung

970

Hualien Tzu Chi Medical Center, Hualien City

1142

Auckland Clinical Studies Limited, Auckland

1407

Tokuda Hospital - Sofia, Sofia

1431

MHAT Alexandrovska Medical University, Sofia, Sofia

1606

MMA Hospital of Active Treatment, Sofia

1797

MHAT Sofia Med, Sofia

2001

Waikato Hospital (District Health Board), Hamilton

2050

Royal Prince Alfred Hospital, Camperdown

2137

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital Westmead, Westmead

3004

The Alfred Hospital, Melbourne

3011

Footscray Hospital, Footscray

3050

The Royal Melbourne Hospital, Parkville

3065

St. Vincent's Hospital, Fitzroy

3084

Austin Health, Heidelberg

3168

Monash Medical Centre, Clayton

4103

Hospital Universitario Virgen del Rocio, Seville

5000

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth

10002

National Taiwan University Hospital, Taipei

10630

Cathay General Hospital, Taipei

11354

Sing Chan Private Practice, Flushing

11355

New Discovery, LLC, Flushing

16059

University of Uludag, Bursa

19107

Jefferson Medical College, Philadelphia

Xiaoli Ma, PC, Philadelphia

20142

Azienda Ospedale San Paolo, Milan

21228

Digestive Disease Associates, PA, Catonsville

21280

Dicle University Medical Faculty Department of Infectious Diseases, Diyarbakır

33136

University of Miami, Miami

34098

Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon, Istanbul

35100

Azienda Ospedaliera di Padova, Padua

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

35121

Azienda Ospedaliera di Padova, Padua

40138

Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi, Bologna

Istituto Europeo di Oncologia, Bologna

48202

Henry Ford Health System, Detroit

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

60002

Chiayi Christian Hospital, Chiayi City

67091

Hopital Civil de Strasbourg, Strasbourg

70403

National Cheng Kung University Hospital, Tainan City

71100

Azienda Ospedaliero Universitaria Ospedali Riuniti di, Foggia

75651

Hopital Pitie Salpetriere, Paris

76012

Texas Clinical Research Institute, LLC, Arlington

77005

Kelsey Research Foundation, Houston

80756

Kaohsiung Med. College Hosp. Dept. of Internal Medicine, Kaohsiung City

90020

Coalition of Inclusive Medicine, Los Angeles

91105

Huntington Medical Research Institutes, Pasadena

92105

Research and Education, Inc., San Diego

92110

Hopital Beaujon, Clichy

94304

Stanford University Medical Center, Palo Alto

94804

Hopital Paul Brousse, Villejuif

95128

Silicon Valley Research Institute, San Jose

98124

Policlinico Universitario G. Martino via Consolare, Messina

110029

All India Institute of Medical Sciences, New Delhi

110060

Sir Ganga Ram Hospital, New Delhi

110070

Institute of Liver and Biliary Sciences, New Delhi

115446

Scientific Research Institute of Nutrition, Moscow

117198

People's Friendship University of Russia, Moscow

119228

National University Hospital Singapore, Singapore

119435

1st Moscow State Medical University University Clinical Hospital #3, Moscow

121170

"Limited Liability Company Modern Medicine Clinic", Moscow

160012

Postgraduate Institute of Medical Education & Research, Chandigarh

169608

Singapore General Hospital, Singapore

191167

Municipal Clinical Hospital n.a. S.P. Botkin, Saint Petersburg

197376

Research Institute of Influenza, Saint Petersburg

300736

Spitalul Clinic Judetean de Urgenta Timisoara, Timișoara

302001

S. R Kalla Memorial Gastro & General Hospital, Jaipur

302004

SMS Medical College & Hospital, Jaipur

395002

Nirmal Hospital, Surat

398043

Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases, Lipetsk

400008

BYL Nair Hospital & T N Medical College, Mumbai

400012

Seth GS Medical College and KEM Hospital, Mumbai

440003

Government Medical College and Superspecialty Hospital, Nagpur

440010

Midas Multispecialty Hospital, Nagpur

443063

Medical Company Hepatology, Samara

500004

Gleneagles Global Hospital, Hyderabad

500058

Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals, Hyderabad

529889

Changi General Hospital Pte Ltd., Singapore

600113

YR Gaitonde Centre for AIDS Research and Education, Chennai

602702

Kosin University College of Medicine, Busan

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

630084

Institute of Clinical Immunology RAMS, Clinic of Immunopathology, Novosibirsk

630099

Scientific Research Institute of Clinical Immunology, Novosibirsk

641005

VGM Hospital, Coimbatore

700020

Postgraduate Institute of Medical Education & Research, Kolkata

700506

Gastromedica SRL, Iași

900709

Spitatul Clinic de Boli Infectioase Constanta, Constanța

02111

Tufts Medical Center, Inc, Boston

T2N 4Z6

University of Calgary, Calgary

T6G 2X8

Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine, Edmonton

V5Z 1H2

Liver and Intestinal Research Centre, Vancouver

V5Z 1M9

Gordon and Leslie Diamond Health Care Centre, Vancouver

V6A 4B6

Dr. John Farley, Inc., Vancouver

V6Z 2C7

Vancouver Infectious Disease Research and Care Centre, Vancouver

V6Z 2K5

Gastrointestinal Research Institute (GIRI), Vancouver

R3E 3P4

University of Manitoba, Health Sciences Center, Winnipeg

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 2C4

University Health Network / Toronto General Hospital, Toronto

M5T 2S8

Inspiration Research Limited, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

Unknown

Queen Mary Hospital, Hong Kong

Princess Margaret Hospital, Lai Chi Kok

Prince of Wales Hospital, Shatin

Alice Ho Miu Ling Nethersole Hospital, Tai Po

Tuen Mun Hospital, Tuenmen

700 094

Peerless Hospital & B.K.Roy Research Center, Kolkata

400 012

Global Hospital Super Specialty & Transplant Centre, Pārel

812-8582

Kyushu University Hospital, Fukuoka

803-8505

Shin-Kokura Hospital, Fukuoka

810-8563

National Hospital Organization Kyushu Medical Center, Fukuoka

760-8557

Kagawa Prefectural Central Hospital, Kagawa

650-0047

Kobe City Medical Center General Hospital, Kobe

400-8506

Yamanashi Prefectural Central Hospital, Kofu

830-0011

Kurume University Hospital, Kurume

602-8566

Kyoto Prefectural University of Medicine, Kyoto

180-8610

Japan Red Cross Musashino Hospital, Musashino

663-8501

Hyogo College of Medicine, Nishinomiya

700-8558

Okayama University Hospital, Okayama

543-8555

Osaka Red Cross Hospital, Osaka

545-8586

Osaka University Hospital, Osaka

856-8562

National Hospital Organization Nagasaki Medical Center, Ōmura

060-8648

Hokkaido University Hospital, Sapporo

113-8519

Medical Hospital of Tokyo Medical and Dental University, Tokyo

15-540

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika, Bialystok

41-500

Szpital Specjalistyczny, Chorzów

91-347

SPZOZ, Wojewódzki Specjalistyczny Szpital, Lodz

01-201

SP ZOZ Wojewódzki Szpital Zakazny, Warsaw

50-349

Centrum Badan Klinicznych, Wroclaw

021105

"Institutul National de Boli Infectioase Prof. Dr. Matei Bals", Bucharest

030303

"Centrul Medical de Diagnostic si Tratament Dr. Victor Babes", Bucharest

602-739

Pusan National University Hospital, Busan

330-721

SoonChunHyang University Hospital Cheonan, Cheonan

700-712

Keimyung University Dongsan Medical Center, Daegu

700-721

Kyungpook National University Hospital, Daegu

302-718

Konyang University Hospital, Daejeon

411-706

Inje University Ilsan Paik Hospital, Gyeonggi-do

443-380

Ajou University Hospital, Gyeonggi-do

463-707

Seoul National University Bundang Hospital, Gyeonggi-do

110-744

Seoul National University Hospital, Seoul

120-752

Severance Hospital Yonsei University Health System, Seoul

135-710

Samsung Medical Center, Seoul

135-720

Gangnam Severance Hospital, Seoul

137-701

Seoul Saint Mary Hospital, Seoul

138-736

Asan Medical Center, Seoul

143-729

Konkuk University Medical Center, Seoul

152-703

Korea University Guro Hospital, Seoul

156-707

SMG-SNU Boramae Medical Center, Seoul

156-755

Chung-Ang University Hospital, Seoul

682-714

Ulsan University Hospital, Ulsan

220-701

Yonsei Unversity Wonju, Wŏnju

626-770

Pusan National University Yangsan Hospital, Yangsan

08035

Hospital Universitari Vall d'Hebron, Barcelona

06100

Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci, Ankara

E1 1BB

Barts & The London NHS Trust, London

NW3 2QG

Royal Free Hospital, London

SE5 9RS

King's College Hospital, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY