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

Last updated: September 22, 2023
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

TDF

TAF

TDF Placebo

Clinical Study ID

NCT01940341
GS-US-320-0108
2013-000626-63
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

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

Total Participants: 426
Treatment Group(s): 4
Primary Treatment: TDF
Phase: 3
Study Start date:
September 12, 2013
Estimated Completion Date:
August 31, 2022

Study Description

Study GS-US-320-0108 is a multi-center clinical trial, planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort was registered separately (NCT02836236) on ClinicalTrials.gov as the China cohort will not be part of the main study analysis.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St. Vincent's Hospital

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Western Hospital- Footscray Hospital

    Footscray, Victoria 3011
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Zeidler Ledcor Centre Division of Gastroenterology

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Dr. John Farley Inc.

    Vancouver, British Columbia V6A 4B6
    Canada

    Site Not Available

  • Gastrointestinal Research Institute (GIRI)

    Vancouver, British Columbia V6Z 2K5
    Canada

    Site Not Available

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Liver and Intestinal Research Centre

    Vancouver, British Columbia V5Z 1H3
    Canada

    Site Not Available

  • Vancouver Infectious Disease Research and Care Centre

    Vancouver, British Columbia V6Z 2C7
    Canada

    Site Not Available

  • University of Manitoba

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • empty

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Inspiration Research Limited

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Toronto Liver Centre

    Toronto, Ontario M6H 3M1
    Canada

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The 1st Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou 500000
    China

    Site Not Available

  • The People's Hospital of Hainan Province

    Haikou, Hainan 570311
    China

    Site Not Available

  • The 3rd Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050051
    China

    Site Not Available

  • Princess Margaret Hospital

    Kowloon, Hong Kong
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • XiangYa Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Jiangsu Provincial People' Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110022
    China

    Site Not Available

  • Jinan Infectious Disease Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • First Affiliated Hospital of Xi'an Jiaotong

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • No.1 Hospital Affiliated to Kunming Medical College

    Kunming, Yunnan 650032
    China

    Site Not Available

  • No. 302 PLA Hospital

    Beijing,
    China

    Site Not Available

  • 85 Hospital of People's Liberation Army

    Shanghai, 200052
    China

    Site Not Available

  • Tianjin Infectious Disease Hospital

    Tianjin,
    China

    Site Not Available

  • Hôpital de la Croix Rousse

    Lyon, Rhône-Alpes 69317
    France

    Site Not Available

  • empty

    Créteil, Île-de-France 94010
    France

    Site Not Available

  • Hopital Henri Mondor

    Créteil Cedex, Île-de-France 94010
    France

    Site Not Available

  • empty

    Clichy, 92110
    France

    Site Not Available

  • Hopital Beaujon

    Clichy Cedex, 92110
    France

    Site Not Available

  • Hôpital de la Croix Rousse

    Lyon cedex 04, 69317
    France

    Site Not Available

  • Hopital Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Hopital Civil de Strasbourg- CHU Service

    Strasbourg, 67000
    France

    Site Not Available

  • Hopital Paul Brousse

    Villejuif, 94800
    France

    Site Not Available

  • empty

    Villejuif Cedex, 94804
    France

    Site Not Available

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR
    Hong Kong

    Site Not Available

  • Princess Margaret Hospital

    Kwai Chung,
    Hong Kong

    Site Not Available

  • Princess Margaret Hospital

    Lai Chi Kok,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Shatin,
    Hong Kong

    Site Not Available

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po,
    Hong Kong

    Site Not Available

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

    Hyderabad, Andhra Pradesh 500058
    India

    Site Not Available

  • Global Hospitals

    Hyderabad, Andhra Pradesh 500004
    India

    Site Not Available

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    Rajinder Nagar, Delhi 110060
    India

    Site Not Available

  • Nirmal Hospital

    Surat, Gujarat 395002
    India

    Site Not Available

  • Medanta-The Medicity

    Gurgaon, Haryana 122001
    India

    Site Not Available

  • MS Ramaiah Medical College and Hospital

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • Seth GS Medical College and KEM Hospital

    Mumbai, Maharastra 400012
    India

    Site Not Available

  • Global Hospital Super Specialty & Transplant Centre

    Parel, Mumbai 400 012
    India

    Site Not Available

  • Dayanand Medical College & Hospital

    Ludhiana, Punjab 141001
    India

    Site Not Available

  • S. R Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan 302001
    India

    Site Not Available

  • Institute of Post Graduate Medical Education And Research

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012
    India

    Site Not Available

  • empty

    Chandigath, 160012
    India

    Site Not Available

  • empty

    Coimbatore, 641005
    India

    Site Not Available

  • empty

    Lucknow, 226014
    India

    Site Not Available

  • Midas Multispecialty Hospital

    Nagpur, 440010
    India

    Site Not Available

  • Institute of Liver and Biliary Sciences

    New Delhi, 110070
    India

    Site Not Available

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia 71013
    Italy

    Site Not Available

  • Azienda Ospedaliera S. Orsola - Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Cisanello Pisa, 56124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali

    Foggia, 71122
    Italy

    Site Not Available

  • Azienda Ospedale San Paolo

    Milano, 20142
    Italy

    Site Not Available

  • Azienda Ospedaliero- Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • Kurume University Hospital

    Kurume-shi, Fukuoka-ken 830-0011
    Japan

    Site Not Available

  • Kyushu University Hospital Fukuoka

    Fukuoka, Fukuoka-shi 812-8582
    Japan

    Site Not Available

  • National Hospital Organization Nagasaki Medical Center

    Omura-shi, Nagasaki 856-8562
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Kyushu University Hospital Fukuoka

    Fukuoka-shi, 812-8582
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Hyogo, 650-0047
    Japan

    Site Not Available

  • Kohnodai Hospital, National Center for Global Health and Medicine

    Ichikawa, 272-0827
    Japan

    Site Not Available

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-0017
    Japan

    Site Not Available

  • Shin-Kokura Hospital

    Kitakyushu, 803-8505
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047
    Japan

    Site Not Available

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume, 830-0011
    Japan

    Site Not Available

  • Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Japan Red Cross Musashino Hospital

    Musashino, 180-8610
    Japan

    Site Not Available

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • National Hospital Organization Nagasaki Medical Center

    Omura, 856-8562
    Japan

    Site Not Available

  • Osaka Red Cross Hospital

    Osaka, 543-8555
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, 060-8648
    Japan

    Site Not Available

  • Medical Hospital of Tokyo Medical and Dental University

    Tokyo, 113-8519
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Site Not Available

  • SoonChunHyang University Hospital Cheonan

    Cheonan, Chungcheongnam-Do 330-721
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do 50612
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, 602-739
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu, 42601
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • empty

    Gangnam-gu, 135-720
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul, 06273
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul Saint Mary Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Yonsei University, Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Auckland Clinical Studies Limited

    Grafton, Auckland 1142
    New Zealand

    Site Not Available

  • Auckland Clinical Studies Limited

    Auckland, 1010
    New Zealand

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

    Bialystok, 15-540
    Poland

    Site Not Available

  • Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza

    Bydgoszcz, 85-030
    Poland

    Site Not Available

  • Szpital Specjalistyczny w Chorzowie Oddział

    Chorzow, 41-500
    Poland

    Site Not Available

  • SPZOZ, Wojewódzki Specjalistyczny Szpital

    Lodz, 91-347
    Poland

    Site Not Available

  • Centrum Badan Klinicznych - Przychodnia Badan

    Wroclaw, 50-349
    Poland

    Site Not Available

  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

    Bucharest, Bucuresti 021105
    Romania

    Site Not Available

  • Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"

    Bucuresti, 030303
    Romania

    Site Not Available

  • Institutul National de Boli Infectioase Prof.Dr. Matei Bals

    Bucuresti, 21105
    Romania

    Site Not Available

  • Spitatul Clinic de Boli Infectioase Constanta

    Constanta, 900708
    Romania

    Site Not Available

  • Gastromedica SRL

    Iasi, 700506
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Timisoara

    Timisoara, 300736
    Romania

    Site Not Available

  • Infection Center LLC Building 20, MSH #163 Territory Koltsovo

    Koltsovo, Novosibirsk 630559
    Russian Federation

    Site Not Available

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

    Moscow, 119991
    Russian Federation

    Site Not Available

  • Infectious Clinical Hospital #1 of Moscow Healthcare Department

    Moscow, 125367
    Russian Federation

    Site Not Available

  • Limited Liability Company "Modern Medicine Clinic"

    Moscow, 121293
    Russian Federation

    Site Not Available

  • Novosibirsk State Medical University

    Novosibirsk, 630084
    Russian Federation

    Site Not Available

  • Scientific Research Institute of Clinical Immunology

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Clinical Infectious Hospital named after S.P.Botkin

    Saint-Petersburg, 191167
    Russian Federation

    Site Not Available

  • Kirov Medical Military Academy

    Saint-Petersburg, 194044
    Russian Federation

    Site Not Available

  • Research Institute of Influenza

    Saint-Petersburg, 197376
    Russian Federation

    Site Not Available

  • Changi General Hospital Pte Ltd.

    Singapore, 529889
    Singapore

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28020
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 4103
    Spain

    Site Not Available

  • Hualien Tzu Chi Medical Center

    Hualien, 970
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Hospital

    Hualien City, 970
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Dicle University Medical Faculty Department of Infectious Diseases

    Diyarbakir, Diyarbakri 21280
    Turkey

    Site Not Available

  • Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

    Ankara, 06590
    Turkey

    Site Not Available

  • Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji

    Bursa, 16059
    Turkey

    Site Not Available

  • University of Uludag

    Gorukle-Bursa, 16059
    Turkey

    Site Not Available

  • Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi

    Istanbul, 34098
    Turkey

    Site Not Available

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35040
    Turkey

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire NG7 2UH
    United Kingdom

    Site Not Available

  • Barts and The London NHS Trust Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Asian Pacific Liver Center

    Los Angeles, California 90020
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • Huntington Medical Research Institutes

    Pasadena, California 91105
    United States

    Site Not Available

  • Research and Education, Inc.

    San Diego, California 92105
    United States

    Site Not Available

  • University California San Francisco (UCSF)

    San Francisco, California 94110
    United States

    Site Not Available

  • Silicon Valley Research Institute

    San Jose, California 95128
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Digestive Disease Associates, PA

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Digestive Disease Associates, PA

    Catonsville, Maryland 21228
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • ID Care

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • New Discovery, LLC

    Flushing, New York 11355
    United States

    Site Not Available

  • Sing Chan Private Practice

    Flushing, New York 11354
    United States

    Site Not Available

  • Xiaoli Ma, PC

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • The North Texas Research Institute

    Arlington, Texas 76012
    United States

    Site Not Available

  • empty

    Houston, Texas 77005
    United States

    Site Not Available

  • Hunter Holmes McGuire VA DVMC

    Richmond, Virginia 23249
    United States

    Site Not Available

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