Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
TDF
TAF
TAF 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.
- HBeAg-positive, chronic hepatitis B with all of the following:
- HBeAg-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 the baseline visit.
- 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 Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaSite Not Available
Concord Repatriation General Hospital
Concord, New South Wales 2137
AustraliaSite Not Available
Westmead Hospital Westmead
Westmead, New South Wales 2145
AustraliaSite Not Available
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
Footscray Hospital
Footscray, Victoria 3011
AustraliaSite Not Available
Austin Health
Heidelberg, Victoria 3084
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
The 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
Westmead Hospital Westmead
NSW, 2145
AustraliaSite Not Available
MHAT Alexandrovska Medical University, Sofia
Sofia, 1431
BulgariaSite Not Available
MHAT Sofia Med
Sofia, 1797
BulgariaSite Not Available
MMA Hospital of Active Treatment
Sofia, 1606
BulgariaSite Not Available
Tokuda Hospital - Sofia
Sofia, 1407
BulgariaSite Not Available
University of Calgary
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine
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 1H2
CanadaSite Not Available
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia V6Z 2C7
CanadaSite Not Available
University of Manitoba, Health Sciences Center
Winnipeg, Manitoba R3E 3P4
CanadaSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Inspiration Research Limited
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Toronto Liver Centre
Toronto, Ontario M6H 3M1
CanadaSite Not Available
University Health Network / Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaSite Not Available
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong 510630
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
PLA 302 Hospital
Beijing, 100039
ChinaSite Not Available
85 Hospital of People's Liberation Army
Shanghai, 200052
ChinaSite Not Available
Hopital Beaujon
Clichy, 92110
FranceSite Not Available
Hopital Beaujon
Clichy Cedex, 92110
FranceSite Not Available
Hopital Henri Mondor
Creteil Cedex, 94010
FranceSite Not Available
Hôpital de la Croix Rousse
Lyon cedex, 04 69317
FranceSite Not Available
Hopital Pitie Salpetriere
Paris, 75651
FranceSite Not Available
Hopital Civil de Strasbourg
Strasbourg, 67091
FranceSite Not Available
Service d'Hepatogastroenterologie
Vandoeuvre Les Nancy, 54511
FranceSite Not Available
Hopital Paul Brousse
Villejuif, 94804
FranceSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Princess Margaret Hospital
Lai Chi Kok,
Hong KongSite Not Available
Prince of Wales Hospital
Sha Tin,
Hong KongSite Not Available
Alice Ho Miu Ling Nethersole Hospital
Tai Po,
Hong KongSite Not Available
Tuen Mun Hospital
Tuen Mun,
Hong KongSite Not Available
Medanta-The Medicity
Gurgaon, Haryana 122001
IndiaSite Not Available
BYL Nair Hospital & T N Medical College
Mumbai, Maharashtra 400008
IndiaSite Not Available
Government Medical College and Superspecialty Hospital
Nagpur, Maharashtra 440003
IndiaSite Not Available
Midas Multispecialty Hospital
Nagpur, Maharashtra 440010
IndiaSite Not Available
PD Hinduja Hospital & Medical Research Center
Mahim, Mumbai 400016
IndiaSite Not Available
SMS Medical College & Hospital
Jaipur, Rajasthan 302004
IndiaSite Not Available
MS Ramaiah Medical College and Hospital
Bangalore, 560054
IndiaSite Not Available
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012
IndiaSite Not Available
empty
Chandigath, 160012
IndiaSite Not Available
YR Gaitonde Centre for AIDS Research and Education
Chennai, 600113
IndiaSite Not Available
VGM Hospital
Coimbatore, 641005
IndiaSite Not Available
Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
Hyderabad, 500058
IndiaSite Not Available
Gleneagles Global Hospital
Hyderabad, 500004
IndiaSite Not Available
S. R Kalla Memorial Gastro & General Hospital
Jaipur, 302001
IndiaSite Not Available
Lakeshore Hospital
Kochi, 682040
IndiaSite Not Available
Peerless Hospital & B.K.Roy Research Center
Kolkata, 700 094
IndiaSite Not Available
Postgraduate Institute of Medical Education & Research
Kolkata, 700020
IndiaSite Not Available
empty
Lucknow, 226014
IndiaSite Not Available
empty
Ludhiana, 141001
IndiaSite Not Available
Seth GS Medical College and KEM Hospital
Mumbai, 400012
IndiaSite Not Available
All India Institute of Medical Sciences
New Delhi, 110029
IndiaSite Not Available
Institute of Liver and Biliary Sciences
New Delhi, 110070
IndiaSite Not Available
Sir Ganga Ram Hospital
New Delhi, 110060
IndiaSite Not Available
Global Hospital Super Specialty & Transplant Centre
Parel, 400 012
IndiaSite Not Available
Nirmal Hospital
Surat, 395002
IndiaSite Not Available
YR Gaitonde Centre for AIDS Research and Education Chennai
Taramani, 600113
IndiaSite Not Available
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, 40138
ItalySite Not Available
Istituto Europeo di Oncologia
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti di
Foggia, 71100
ItalySite Not Available
Policlinico Universitario G. Martino via Consolare
Messina, 98124
ItalySite Not Available
Azienda Ospedale San Paolo
Milano, 20142
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35121
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
ItalySite Not Available
Casa Sollievodella Soferrenza IRCCS
San Giovanni Rotondo, 71013
ItalySite Not Available
Kyushu University Hospital
Fukuoka, Fukuoka-shi 812-8582
JapanSite Not Available
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
JapanSite Not Available
Shin-Kokura Hospital
Fukuoka, 803-8505
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, 760-8557
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
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
Osaka University Hospital
Osaka, 545-8586
JapanSite Not Available
Hokkaido University Hospital
Sapporo, 060-8648
JapanSite Not Available
Osaka University Hospital
Suita, 565-0871
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
Kosin University College of Medicine
Busan, Seo-gu 602702
Korea, Republic ofSite Not Available
Pusan National University Hospital
Busan, 602-739
Korea, Republic ofSite Not Available
SoonChunHyang University Hospital Cheonan
Cheonan, 330-721
Korea, Republic ofSite Not Available
Keimyung University Dongsan Medical Center
Daegu, 700-712
Korea, Republic ofSite Not Available
Kyungpook National University Hospital
Daegu, 700-721
Korea, Republic ofSite Not Available
Konyang University Hospital
Daejeon, 302-718
Korea, Republic ofSite Not Available
Inje University Ilsan Paik Hospital
Goyang-si, 411-706
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Gyeonggi-Do, 463-707
Korea, Republic ofSite Not Available
Ajou University Hospital
Gyeonggi-do, 443-380
Korea, Republic ofSite Not Available
Inje University Ilsan Paik Hospital
Gyeonggi-do, 411-706
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 138-736
Korea, Republic ofSite Not Available
Chung-Ang University Hospital
Seoul, 156-755
Korea, Republic ofSite Not Available
Gangnam Severance Hospital
Seoul, 135-720
Korea, Republic ofSite Not Available
Konkuk University Medical Center
Seoul, 143-729
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 152-703
Korea, Republic ofSite Not Available
SMG-SNU Boramae Medical Center
Seoul, 156-707
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 110-744
Korea, Republic ofSite Not Available
Seoul Saint Mary Hospital
Seoul, 137-701
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 120-752
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon, 443-380
Korea, Republic ofSite Not Available
Ulsan University Hospital
Ulsan, 682-714
Korea, Republic ofSite Not Available
Yonsei Unversity Wonju
Wŏnju, 220-701
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Yangsan, 626-770
Korea, Republic ofSite Not Available
Auckland Clinical Studies Limited
Grafton, Auckland 1142
New ZealandSite Not Available
Auckland Clinical Studies Limited
Auckland, 1142
New ZealandSite Not Available
Waikato Hospital (District Health Board)
Hamilton, 2001
New ZealandSite Not Available
The Hepatitis Foundation of New Zealand
Whakatane, 3120
New ZealandSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
Bialystok, 15-540
PolandSite Not Available
Szpital Specjalistyczny
Chorzow, 41-500
PolandSite Not Available
SPZOZ, Wojewódzki Specjalistyczny Szpital
Lodz, 91-347
PolandSite Not Available
SP ZOZ Wojewódzki Szpital Zakazny
Warszawa, 01-201
PolandSite Not Available
Centrum Badan Klinicznych
Wroclaw, 50-349
PolandSite Not Available
Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
Bucharest, 030303
RomaniaSite Not Available
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucuresti, 021105
RomaniaSite Not Available
Constanta Clinical Hosp. for Infectious Diseases (attn: Halikidis Stela, MD)
Constanta, 900708
RomaniaSite Not Available
Spitatul Clinic de Boli Infectioase Constanta
Constanţa, 900709
RomaniaSite Not Available
Gastromedica SRL
Iasi, 700506
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Timisoara
Timisoara, 300736
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Timisoara
Timişoara, 300736
RomaniaSite Not Available
Karaganda State Medical Institute
Koltsovo, Novosibirsk 630559
Russian FederationSite Not Available
Chita State Medical Academy, Curative-Diagnostic Clinic
Chita, 672039
Russian FederationSite Not Available
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg, 620102
Russian FederationSite Not Available
Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Lipetsk, 398043
Russian FederationSite Not Available
1st Moscow State Medical University University Clinical Hospital #3
Moscow, 119435
Russian FederationSite Not Available
Limited Liability Company "Modern Medicine Clinic"
Moscow, 121170
Russian FederationSite Not Available
People's Friendship University of Russia
Moscow, 117198
Russian FederationSite Not Available
Scientific Research Institute of Nutrition
Moscow, 115446
Russian FederationSite Not Available
Institute of Clinical Immunology RAMS, Clinic of Immunopathology
Novosibirsk, 630084
Russian FederationSite Not Available
Scientific Research Institute of Clinical Immunology
Novosibirsk, 630099
Russian FederationSite Not Available
Municipal Clinical Hospital n.a. S.P. Botkin
Saint-Petersburg, 191167
Russian FederationSite Not Available
Research Institute of Influenza
Saint-Petersburg, 197376
Russian FederationSite Not Available
Medical Company Hepatology
Samara, 443063
Russian FederationSite Not Available
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102
Russian FederationSite Not Available
Changi General Hospital Pte Ltd.
Singapore, 529889
SingaporeSite Not Available
National University Hospital Singapore
Singapore, 119228
SingaporeSite Not Available
Singapore General Hospital
Singapore, 169608
SingaporeSite Not Available
Hospital Alcorcón
Alcorcon, 28922
SpainSite Not Available
Hospital Germans Trias i Pujol
Badalona, 8916
SpainSite 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
Hospital La Fe
Valencia, 46026
SpainSite Not Available
Chiayi Christian Hospital
Chia-Yi, 60002
TaiwanSite Not Available
Chiayi Christian Hospital
Chiayi, 60002
TaiwanSite Not Available
Hualien Tzu Chi Medical Center
Hualien, 970
TaiwanSite Not Available
Kaohsiung Med. College Hosp. Dept. of Internal Medicine
Kaohsiung, 80756
TaiwanSite Not Available
Far-Eastern Memorial Hospital
New Taipei City, 220
TaiwanSite Not Available
China Medical University Hospital
Taichung, 404
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 70403
TaiwanSite Not Available
Cathay General Hospital
Taipei, 10630
TaiwanSite Not Available
Far-Eastern Memorial Hospital
Taipei, 220
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
Ankara, 06100
TurkeySite Not Available
University of Uludag
Bursa, 16059
TurkeySite Not Available
Dicle University Medical Faculty Department of Infectious Diseases
Diyarbakir, 21280
TurkeySite Not Available
University of Uludag
Gorukle-Bursa, 16059
TurkeySite Not Available
Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon
Istanbul, 34098
TurkeySite Not Available
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100
TurkeySite Not Available
Barts & The London NHS Trust
London, E1 1BB
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QG
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United KingdomSite Not Available
Coalition of Inclusive Medicine
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
Kaiser Permanente
San Francisco, California 94118
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
Institute of Human Virology
Baltimore, Maryland 21201
United StatesSite Not Available
Digestive Disease Associates, PA
Catonsville, Maryland 21228
United StatesSite Not Available
Tufts Medical Center, Inc
Boston, Massachusetts 02111
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
Jefferson Medical College
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Xiaoli Ma, PC
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Texas Clinical Research Institute, LLC
Arlington, Texas 76012
United StatesSite Not Available
Kelsey Research Foundation
Houston, Texas 77005
United StatesSite Not Available
Texas Liver Institute/American Research Corporation
San Antonio, Texas 78215
United StatesSite Not Available
Hunter Holmes McGuire VA DVAMC
Richmond, Virginia 23298
United StatesSite Not Available
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