Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
TDF
TAF
TDF Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Ability to understand and sign a written informed consent form, which must be obtainedprior to initiation of study procedures.
- Adult males and non-pregnant, non-lactating females.
- Documented evidence of chronic HBV infection.
- Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following:
- HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening.
- Screening HBV DNA ≥ 2 x 10^4 IU/mL.
- Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN).
- Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment withany nucleoside or nucleotide analogue), OR treatment-experienced participants (definedas participants meeting all entry criteria [including HBV DNA and serum ALT criteria]and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue).
- Previous treatment with interferon (pegylated or non pegylated) must have ended atleast 6 months prior to Baseline.
- Adequate renal function.
- Normal electrocardiogram (ECG).
Exclusion
Key Exclusion Criteria:
- Females who are breastfeeding.
- Males and females of reproductive potential who are unwilling to use an "effective",protocol-specified method(s) of contraception during the study.
- Co-infection with hepatitis C virus, human immunodeficiency virus (HIV), or hepatitisD virus.
- Evidence of hepatocellular carcinoma.
- Any history of, or current evidence of, clinical hepatic decompensation.
- Abnormal hematological and biochemical parameters, including aspartateaminotransferase (AST) > 10 x ULN
- Received solid organ or bone marrow transplant.
- History of malignancy within the past 5 years, with the exception of specific cancersthat are cured by surgical resection; individuals under evaluation for possiblemalignancy are not eligible.
- Currently receiving therapy with immunomodulators (eg, corticosteroids),investigational agents, nephrotoxic agents, or agents capable of modifying renalexcretion.
- Individuals receiving ongoing therapy with drugs not to be used with tenofoviralafenamide or tenofovir disoproxil fumarate or individuals with a knownhypersensitivity to study drugs, metabolites, or formulation excipients.
- Current alcohol or substance abuse judged by the investigator to potentially interferewith participant compliance.
- Any other clinical condition or prior therapy that, in the opinion of theInvestigator, would make the participant unsuitable for the study or unable to complywith dosing requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Monash Medical Centre
Clayton, Victoria 3168
AustraliaSite Not Available
St. Vincent's Hospital
Fitzroy, Victoria 3065
AustraliaSite Not Available
Western Hospital- Footscray Hospital
Footscray, Victoria 3011
AustraliaSite Not Available
Austin Health
Heidelberg, Victoria 3084
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Royal Perth Hospital
Perth, Western Australia 6000
AustraliaSite Not Available
University of Calgary
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Zeidler Ledcor Centre Division of Gastroenterology
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
Dr. John Farley Inc.
Vancouver, British Columbia V6A 4B6
CanadaSite Not Available
Gastrointestinal Research Institute (GIRI)
Vancouver, British Columbia V6Z 2K5
CanadaSite Not Available
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Liver and Intestinal Research Centre
Vancouver, British Columbia V5Z 1H3
CanadaSite Not Available
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia V6Z 2C7
CanadaSite Not Available
University of Manitoba
Winnipeg, Manitoba R3E 3P4
CanadaSite Not Available
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Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Inspiration Research Limited
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Toronto Liver Centre
Toronto, Ontario M6H 3M1
CanadaSite Not Available
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
The 1st Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530021
ChinaSite Not Available
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou 500000
ChinaSite Not Available
The People's Hospital of Hainan Province
Haikou, Hainan 570311
ChinaSite Not Available
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei 050051
ChinaSite Not Available
Princess Margaret Hospital
Kowloon, Hong Kong
ChinaSite Not Available
Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology
Wuhan, Hubei 430030
ChinaSite Not Available
XiangYa Hospital Central South University
Changsha, Hunan 410008
ChinaSite Not Available
Jiangsu Provincial People' Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330000
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110022
ChinaSite Not Available
Jinan Infectious Disease Hospital
Jinan, Shandong 250021
ChinaSite Not Available
First Affiliated Hospital of Xi'an Jiaotong
Xi'an, Shanxi 710061
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
No.1 Hospital Affiliated to Kunming Medical College
Kunming, Yunnan 650032
ChinaSite Not Available
No. 302 PLA Hospital
Beijing,
ChinaSite Not Available
85 Hospital of People's Liberation Army
Shanghai, 200052
ChinaSite Not Available
Tianjin Infectious Disease Hospital
Tianjin,
ChinaSite Not Available
Hôpital de la Croix Rousse
Lyon, Rhône-Alpes 69317
FranceSite Not Available
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Créteil, Île-de-France 94010
FranceSite Not Available
Hopital Henri Mondor
Créteil Cedex, Île-de-France 94010
FranceSite Not Available
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Clichy, 92110
FranceSite Not Available
Hopital Beaujon
Clichy Cedex, 92110
FranceSite Not Available
Hôpital de la Croix Rousse
Lyon cedex 04, 69317
FranceSite Not Available
Hopital Pitie Salpetriere
Paris, 75013
FranceSite Not Available
Hopital Civil de Strasbourg- CHU Service
Strasbourg, 67000
FranceSite Not Available
Hopital Paul Brousse
Villejuif, 94800
FranceSite Not Available
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Villejuif Cedex, 94804
FranceSite Not Available
Queen Mary Hospital
Hong Kong, Hong Kong SAR
Hong KongSite Not Available
Princess Margaret Hospital
Kwai Chung,
Hong KongSite Not Available
Princess Margaret Hospital
Lai Chi Kok,
Hong KongSite Not Available
Prince of Wales Hospital
Sha Tin,
Hong KongSite Not Available
Prince of Wales Hospital
Shatin,
Hong KongSite Not Available
Alice Ho Miu Ling Nethersole Hospital
Tai Po,
Hong KongSite Not Available
Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
Hyderabad, Andhra Pradesh 500058
IndiaSite Not Available
Global Hospitals
Hyderabad, Andhra Pradesh 500004
IndiaSite Not Available
All India Institute of Medical Sciences
New Delhi, Delhi 110029
IndiaSite Not Available
Sir Ganga Ram Hospital
Rajinder Nagar, Delhi 110060
IndiaSite Not Available
Nirmal Hospital
Surat, Gujarat 395002
IndiaSite Not Available
Medanta-The Medicity
Gurgaon, Haryana 122001
IndiaSite Not Available
MS Ramaiah Medical College and Hospital
Bangalore, Karnataka 560054
IndiaSite Not Available
Seth GS Medical College and KEM Hospital
Mumbai, Maharastra 400012
IndiaSite Not Available
Global Hospital Super Specialty & Transplant Centre
Parel, Mumbai 400 012
IndiaSite Not Available
Dayanand Medical College & Hospital
Ludhiana, Punjab 141001
IndiaSite Not Available
S. R Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan 302001
IndiaSite Not Available
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal 700020
IndiaSite Not Available
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
IndiaSite Not Available
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Chandigath, 160012
IndiaSite Not Available
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Coimbatore, 641005
IndiaSite Not Available
empty
Lucknow, 226014
IndiaSite Not Available
Midas Multispecialty Hospital
Nagpur, 440010
IndiaSite Not Available
Institute of Liver and Biliary Sciences
New Delhi, 110070
IndiaSite Not Available
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia 71013
ItalySite Not Available
Azienda Ospedaliera S. Orsola - Malpighi
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Cisanello Pisa, 56124
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali
Foggia, 71122
ItalySite Not Available
Azienda Ospedale San Paolo
Milano, 20142
ItalySite Not Available
Azienda Ospedaliero- Universitaria Pisana
Pisa, 56124
ItalySite Not Available
Kurume University Hospital
Kurume-shi, Fukuoka-ken 830-0011
JapanSite Not Available
Kyushu University Hospital Fukuoka
Fukuoka, Fukuoka-shi 812-8582
JapanSite Not Available
National Hospital Organization Nagasaki Medical Center
Omura-shi, Nagasaki 856-8562
JapanSite Not Available
Osaka University Hospital
Suita, Osaka 565-0871
JapanSite Not Available
Kyushu University Hospital Fukuoka
Fukuoka-shi, 812-8582
JapanSite Not Available
Kobe City Medical Center General Hospital
Hyogo, 650-0047
JapanSite Not Available
Kohnodai Hospital, National Center for Global Health and Medicine
Ichikawa, 272-0827
JapanSite Not Available
Kagawa Prefectural Central Hospital
Kagawa, 760-0017
JapanSite Not Available
Shin-Kokura Hospital
Kitakyushu, 803-8505
JapanSite Not Available
Kobe City Medical Center General Hospital
Kobe, 650-0047
JapanSite Not Available
Yamanashi Prefectural Central Hospital
Kofu, 400-8506
JapanSite Not Available
Kurume University Hospital
Kurume, 830-0011
JapanSite Not Available
Kyoto Prefectural University of Medicine
Kyoto, 602-8566
JapanSite Not Available
Japan Red Cross Musashino Hospital
Musashino, 180-8610
JapanSite Not Available
The Hospital of Hyogo College of Medicine
Nishinomiya, 663-8501
JapanSite Not Available
Okayama University Hospital
Okayama, 700-8558
JapanSite Not Available
National Hospital Organization Nagasaki Medical Center
Omura, 856-8562
JapanSite Not Available
Osaka Red Cross Hospital
Osaka, 543-8555
JapanSite Not Available
Hokkaido University Hospital
Sapporo, 060-8648
JapanSite Not Available
Medical Hospital of Tokyo Medical and Dental University
Tokyo, 113-8519
JapanSite Not Available
Yamagata University Hospital
Yamagata, 990-9585
JapanSite Not Available
SoonChunHyang University Hospital Cheonan
Cheonan, Chungcheongnam-Do 330-721
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do 50612
Korea, Republic ofSite Not Available
Pusan National University Hospital
Busan, 602-739
Korea, Republic ofSite Not Available
Keimyung University Dongsan Medical Center
Daegu, 42601
Korea, Republic ofSite Not Available
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofSite Not Available
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Gangnam-gu, 135-720
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Chung-Ang University Hospital
Seoul, 06973
Korea, Republic ofSite Not Available
Gangnam Severance Hospital
Seoul, 06273
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul Saint Mary Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Yonsei University, Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
Auckland Clinical Studies Limited
Grafton, Auckland 1142
New ZealandSite Not Available
Auckland Clinical Studies Limited
Auckland, 1010
New ZealandSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
Bialystok, 15-540
PolandSite Not Available
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
Bydgoszcz, 85-030
PolandSite Not Available
Szpital Specjalistyczny w Chorzowie Oddział
Chorzow, 41-500
PolandSite Not Available
SPZOZ, Wojewódzki Specjalistyczny Szpital
Lodz, 91-347
PolandSite Not Available
Centrum Badan Klinicznych - Przychodnia Badan
Wroclaw, 50-349
PolandSite Not Available
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, Bucuresti 021105
RomaniaSite Not Available
Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
Bucuresti, 030303
RomaniaSite Not Available
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
Bucuresti, 21105
RomaniaSite Not Available
Spitatul Clinic de Boli Infectioase Constanta
Constanta, 900708
RomaniaSite Not Available
Gastromedica SRL
Iasi, 700506
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Timisoara
Timisoara, 300736
RomaniaSite Not Available
Infection Center LLC Building 20, MSH #163 Territory Koltsovo
Koltsovo, Novosibirsk 630559
Russian FederationSite Not Available
1st Moscow State Medical University University Clinical Hospital #3
Moscow, 119991
Russian FederationSite Not Available
Infectious Clinical Hospital #1 of Moscow Healthcare Department
Moscow, 125367
Russian FederationSite Not Available
Limited Liability Company "Modern Medicine Clinic"
Moscow, 121293
Russian FederationSite Not Available
Novosibirsk State Medical University
Novosibirsk, 630084
Russian FederationSite Not Available
Scientific Research Institute of Clinical Immunology
Novosibirsk, 630091
Russian FederationSite Not Available
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
Russian FederationSite Not Available
Clinical Infectious Hospital named after S.P.Botkin
Saint-Petersburg, 191167
Russian FederationSite Not Available
Kirov Medical Military Academy
Saint-Petersburg, 194044
Russian FederationSite Not Available
Research Institute of Influenza
Saint-Petersburg, 197376
Russian FederationSite Not Available
Changi General Hospital Pte Ltd.
Singapore, 529889
SingaporeSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Puerta de Hierro
Majadahonda, 28020
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 4103
SpainSite Not Available
Hualien Tzu Chi Medical Center
Hualien, 970
TaiwanSite Not Available
Hualien Tzu Chi Hospital
Hualien City, 970
TaiwanSite Not Available
Kaohsiung Medical University Hospital
Kaohsiung, 807
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Dicle University Medical Faculty Department of Infectious Diseases
Diyarbakir, Diyarbakri 21280
TurkeySite Not Available
Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
Ankara, 06590
TurkeySite Not Available
Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji
Bursa, 16059
TurkeySite Not Available
University of Uludag
Gorukle-Bursa, 16059
TurkeySite Not Available
Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi
Istanbul, 34098
TurkeySite Not Available
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35040
TurkeySite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire NG7 2UH
United KingdomSite Not Available
Barts and The London NHS Trust Royal London Hospital
London, E1 1BB
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
Asian Pacific Liver Center
Los Angeles, California 90020
United StatesSite Not Available
Stanford University Medical Center
Palo Alto, California 94304
United StatesSite Not Available
Huntington Medical Research Institutes
Pasadena, California 91105
United StatesSite Not Available
Research and Education, Inc.
San Diego, California 92105
United StatesSite Not Available
University California San Francisco (UCSF)
San Francisco, California 94110
United StatesSite Not Available
Silicon Valley Research Institute
San Jose, California 95128
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Digestive Disease Associates, PA
Baltimore, Maryland 21229
United StatesSite Not Available
Digestive Disease Associates, PA
Catonsville, Maryland 21228
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
ID Care
Hillsborough, New Jersey 08844
United StatesSite Not Available
New Discovery, LLC
Flushing, New York 11355
United StatesSite Not Available
Sing Chan Private Practice
Flushing, New York 11354
United StatesSite Not Available
Xiaoli Ma, PC
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
The North Texas Research Institute
Arlington, Texas 76012
United StatesSite Not Available
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Houston, Texas 77005
United StatesSite Not Available
Hunter Holmes McGuire VA DVMC
Richmond, Virginia 23249
United StatesSite Not Available

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