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

PHASE3CompletedINTERVENTIONAL
Enrollment

426

Participants

Timeline

Start Date

September 12, 2013

Primary Completion Date

September 30, 2015

Study Completion Date

August 31, 2022

Conditions
HBeAg-negative 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 (105)

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Hospital, Kaohsiung City

970

Hualien Tzu Chi Hospital, Hualien City

1010

Auckland Clinical Studies Limited, Auckland

3050

Royal Melbourne Hospital, Parkville

3065

St. Vincent's Hospital, Fitzroy

3168

Monash Medical Centre, Clayton

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

10002

National Taiwan University Hospital, Taipei

11354

Sing Chan Private Practice, Flushing

11355

New Discovery, LLC, Flushing

16059

Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji, Bursa

19107

Xiaoli Ma, PC, Philadelphia

21105

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

21228

Digestive Disease Associates, PA, Catonsville

21280

Dicle University Medical Faculty Department of Infectious Diseases, Diyarbakır

23249

Hunter Holmes McGuire VA DVMC, Richmond

33136

University of Miami, Miami

34098

Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi, Istanbul

35040

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

40138

Azienda Ospedaliera S. Orsola - Malpighi, Bologna

40705

Taichung Veterans General Hospital, Taichung

41944

Kyungpook National University Hospital, Daegu

42601

Keimyung University Dongsan Medical Center, Daegu

48202

Henry Ford Health System, Detroit

50612

Pusan National University Yangsan Hospital, Yangsan

56124

Azienda Ospedaliero- Universitaria Pisana, Pisa

67000

Hopital Civil de Strasbourg- CHU Service, Strasbourg

69317

Hôpital de la Croix Rousse, Lyon

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

71122

Azienda Ospedaliero Universitaria Ospedali, Foggia

90020

Asian Pacific Liver Center, Los Angeles

91105

Huntington Medical Research Institutes, Pasadena

92105

Research and Education, Inc., San Diego

94110

University California San Francisco (UCSF), San Francisco

94304

Stanford University Medical Center, Palo Alto

95128

Silicon Valley Research Institute, San Jose

110029

All India Institute of Medical Sciences, New Delhi

110070

Institute of Liver and Biliary Sciences, New Delhi

119991

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

121293

"Limited Liability Company Modern Medicine Clinic", Moscow

125367

Infectious Clinical Hospital #1 of Moscow Healthcare Department, Moscow

160012

Postgraduate Institute of Medical Education and Research, Chandigarh

191167

Clinical Infectious Hospital named after S.P.Botkin, Saint Petersburg

194044

Kirov Medical Military Academy, Saint Petersburg

197376

Research Institute of Influenza, Saint Petersburg

302001

S. R Kalla Memorial Gastro & General Hospital, Jaipur

395002

Nirmal Hospital, Surat

400012

Seth GS Medical College and KEM Hospital, Mumbai

500004

Global Hospitals, Hyderabad

500058

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

630084

Novosibirsk State Medical University, Novosibirsk

630087

State Novosibirsk Regional Clinical Hospital, Novosibirsk

630091

Scientific Research Institute of Clinical Immunology, Novosibirsk

630559

Infection Center LLC Building 20, MSH #163 Territory Koltsovo, Kol'tsovo

700020

Institute of Post Graduate Medical Education And Research, Kolkata

700506

Gastromedica SRL, Iași

900708

Spitatul Clinic de Boli Infectioase Constanta, Constanța

08844

ID Care, Hillsborough

T2N 4Z6

University of Calgary, Calgary

T6G 2X8

Zeidler Ledcor Centre Division of Gastroenterology, Edmonton

V5Z 1H3

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, Winnipeg

M5G 2C4

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, Kwai Chung

Prince of Wales Hospital, Shatin

Alice Ho Miu Ling Nethersole Hospital, Tai Po

400 012

Global Hospital Super Specialty & Transplant Centre, Pārel

830-0011

Kurume University Hospital, Kurume-shi

812-8582

Kyushu University Hospital Fukuoka, Fukuoka

856-8562

National Hospital Organization Nagasaki Medical Center, Omura-shi

565-0871

Osaka University Hospital, Suita

803-8505

Shin-Kokura Hospital, Kitakyushu

650-0047

Kobe City Medical Center General Hospital, Kobe

180-8610

Japan Red Cross Musashino Hospital, Musashino

663-8501

The Hospital of Hyogo College of Medicine, Nishinomiya

543-8555

Osaka Red Cross Hospital, Osaka

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 w Chorzowie Oddział, Chorzów

91-347

SPZOZ, Wojewódzki Specjalistyczny Szpital, Lodz

50-349

Centrum Badan Klinicznych - Przychodnia Badan, Wroclaw

021105

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

030303

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

03722

Yonsei University, Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

06591

Seoul Saint Mary Hospital, Seoul

06973

Chung-Ang University Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

06590

Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci, Ankara

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

E1 1BB

Barts and The London NHS Trust Royal London Hospital, London

SE5 9RS

King's College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01940341 - Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen | Biotech Hunter | Biotech Hunter