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HBeAg-positive Chronic Hepatitis BPhase 3NCT01940471

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

A Phase 3 study testing TAF and TDF in people with HBeAg-positive Chronic Hepatitis B, run by Gilead Sciences at 160 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)-positive chronic hepatitis B virus (HBV) infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HBeAg-positive Chronic Hepatitis B
What is being tested?
TAF and TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
875 participants
Where
160 sitesin 19 countries
Study dates
11 Sep 2013to 13 Oct 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and sign a written informed consent form, which must be obtained prior 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
Show all 11Show fewer
  • 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 with any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined as 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 at least 6 months prior to the baseline visit.
  • Adequate renal function.
  • Normal electrocardiogram (ECG).

Who cannot join

  • 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 hepatitis D virus.
  • Evidence of hepatocellular carcinoma .
  • Any history of, or current evidence of, clinical hepatic decompensation.
  • Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN.
Show all 13Show fewer
  • Received solid organ or bone marrow transplant.
  • History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible.
  • Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
  • Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

160 sites in 19 countries.

160 sites in 19 countries

South Korea22 sites

  • Kosin University College of Medicine

    Busan, Seo-gu, 602702

  • Pusan National University Hospital

    Busan, 602-739

  • SoonChunHyang University Hospital Cheonan

    Cheonan, 330-721

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Kyungpook National University Hospital

    Daegu, 700-721

  • Konyang University Hospital

    Daejeon, 302-718

  • Inje University Ilsan Paik Hospital

    Gyeonggi-do, 411-706

  • Ajou University Hospital

    Gyeonggi-do, 443-380

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Seoul Saint Mary Hospital

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

  • Konkuk University Medical Center

    Seoul, 143-729

  • Korea University Guro Hospital

    Seoul, 152-703

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

  • Chung-Ang University Hospital

    Seoul, 156-755

  • Ulsan University Hospital

    Ulsan, 682-714

  • Yonsei Unversity Wonju

    Wŏnju, 220-701

  • Pusan National University Yangsan Hospital

    Yangsan, 626-770

Other trials in South Korea

India18 sites

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012

  • YR Gaitonde Centre for AIDS Research and Education

    Chennai, 600113

  • VGM Hospital

    Coimbatore, 641005

  • Gleneagles Global Hospital

    Hyderabad, 500004

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

    Hyderabad, 500058

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • S. R Kalla Memorial Gastro & General Hospital

    Jaipur, 302001

  • Peerless Hospital & B.K.Roy Research Center

    Kolkata, 700 094

  • Postgraduate Institute of Medical Education & Research

    Kolkata, 700020

  • BYL Nair Hospital & T N Medical College

    Mumbai, Maharashtra, 400008

  • Seth GS Medical College and KEM Hospital

    Mumbai, 400012

  • Government Medical College and Superspecialty Hospital

    Nagpur, Maharashtra, 440003

  • Midas Multispecialty Hospital

    Nagpur, Maharashtra, 440010

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Institute of Liver and Biliary Sciences

    New Delhi, 110070

  • Global Hospital Super Specialty & Transplant Centre

    Parel, 400 012

  • Nirmal Hospital

    Surat, 395002

Other trials in India

Japan16 sites

  • Kyushu University Hospital

    Fukuoka, Fukuoka-shi, 812-8582

  • Shin-Kokura Hospital

    Fukuoka, 803-8505

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Kurume University Hospital

    Kurume, 830-0011

  • Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Japan Red Cross Musashino Hospital

    Musashino, 180-8610

  • Hyogo College of Medicine

    Nishinomiya, 663-8501

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, 856-8562

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • Osaka University Hospital

    Osaka, 545-8586

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Medical Hospital of Tokyo Medical and Dental University

    Tokyo, 113-8519

Other trials in Japan

United States15 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Tufts Medical Center, Inc

    Boston, Massachusetts, 02111

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Sing Chan Private Practice

    Flushing, New York, 11354

  • New Discovery, LLC

    Flushing, New York, 11355

  • Kelsey Research Foundation

    Houston, Texas, 77005

  • Coalition of Inclusive Medicine

    Los Angeles, California, 90020

  • University of Miami

    Miami, Florida, 33136

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Huntington Medical Research Institutes

    Pasadena, California, 91105

  • Jefferson Medical College

    Philadelphia, Pennsylvania, 19107

  • Xiaoli Ma, PC

    Philadelphia, Pennsylvania, 19107

  • Research and Education, Inc.

    San Diego, California, 92105

  • Silicon Valley Research Institute

    San Jose, California, 95128

Other trials in United States

Canada12 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine

    Edmonton, Alberta, T6G 2X8

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • University Health Network / Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Inspiration Research Limited

    Toronto, Ontario, M5T 2S8

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Liver and Intestinal Research Centre

    Vancouver, British Columbia, V5Z 1H2

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • Dr. John Farley, Inc.

    Vancouver, British Columbia, V6A 4B6

  • Vancouver Infectious Disease Research and Care Centre

    Vancouver, British Columbia, V6Z 2C7

  • Gastrointestinal Research Institute (GIRI)

    Vancouver, British Columbia, V6Z 2K5

  • University of Manitoba, Health Sciences Center

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2137

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Austin Health

    Heidelberg, Victoria, 3084

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Hospital Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Russia11 sites

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

    Lipetsk, 398043

  • Scientific Research Institute of Nutrition

    Moscow, 115446

  • People's Friendship University of Russia

    Moscow, 117198

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

    Moscow, 119435

  • Limited Liability Company "Modern Medicine Clinic"

    Moscow, 121170

  • Institute of Clinical Immunology RAMS, Clinic of Immunopathology

    Novosibirsk, 630084

  • Scientific Research Institute of Clinical Immunology

    Novosibirsk, 630099

  • Municipal Clinical Hospital n.a. S.P. Botkin

    Saint Petersburg, 191167

  • Research Institute of Influenza

    Saint Petersburg, 197376

  • Medical Company Hepatology

    Samara, 443063

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Italy8 sites

  • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Istituto Europeo di Oncologia

    Bologna, 40138

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di

    Foggia, 71100

  • Policlinico Universitario G. Martino via Consolare

    Messina, 98124

  • Azienda Ospedale San Paolo

    Milan, 20142

  • Azienda Ospedaliera di Padova

    Padova, 35100

  • Azienda Ospedaliera di Padova

    Padova, 35121

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

Other trials in Italy

Taiwan8 sites

  • Chiayi Christian Hospital

    Chiayi City, 60002

  • Hualien Tzu Chi Medical Center

    Hualien City, 970

  • Kaohsiung Med. College Hosp. Dept. of Internal Medicine

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Cathay General Hospital

    Taipei, 10630

  • Far-Eastern Memorial Hospital

    Taipei, 220

Other trials in Taiwan

Hong Kong5 sites

  • 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

Other trials in Hong Kong

Poland5 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

    Bialystok, 15-540

  • Szpital Specjalistyczny

    Chorzów, 41-500

  • SPZOZ, Wojewódzki Specjalistyczny Szpital

    Lodz, 91-347

  • SP ZOZ Wojewódzki Szpital Zakazny

    Warsaw, 01-201

  • Centrum Badan Klinicznych

    Wroclaw, 50-349

Other trials in Poland

Romania5 sites

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

    Bucharest, 021105

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

    Bucharest, 030303

  • Spitatul Clinic de Boli Infectioase Constanta

    Constanța, 900709

  • Gastromedica SRL

    Iași, 700506

  • Spitalul Clinic Judetean de Urgenta Timisoara

    Timișoara, 300736

Other trials in Romania

Turkey (Türkiye)5 sites

  • Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

    Ankara, 06100

  • University of Uludag

    Bursa, 16059

  • Dicle University Medical Faculty Department of Infectious Diseases

    Diyarbakır, 21280

  • Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon

    Istanbul, 34098

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

Other trials in Turkey (Türkiye)

Bulgaria4 sites

  • Tokuda Hospital - Sofia

    Sofia, 1407

  • MHAT Alexandrovska Medical University, Sofia

    Sofia, 1431

  • MMA Hospital of Active Treatment

    Sofia, 1606

  • MHAT Sofia Med

    Sofia, 1797

Other trials in Bulgaria

France4 sites

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Pitie Salpetriere

    Paris, 75651

  • Hopital Civil de Strasbourg

    Strasbourg, 67091

  • Hopital Paul Brousse

    Villejuif, 94804

Other trials in France

United Kingdom4 sites

  • Barts & The London NHS Trust

    London, E1 1BB

  • Royal Free Hospital

    London, NW3 2QG

  • King's College Hospital

    London, SE5 9RS

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

Other trials in United Kingdom

Singapore3 sites

  • National University Hospital Singapore

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169608

  • Changi General Hospital Pte Ltd.

    Singapore, 529889

Other trials in Singapore

New Zealand2 sites

  • Auckland Clinical Studies Limited

    Auckland, 1142

  • Waikato Hospital (District Health Board)

    Hamilton, 2001

Other trials in New Zealand

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen del Rocio

    Seville, 4103

Other trials in Spain

About this study

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

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)-positive chronic hepatitis B virus (HBV) infection.

Read the detailed description

This study GS-US-320-0110 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 are registered separately (NCT02836249) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.

Being tested
TAF, TDF, TAF Placebo, TDF Placebo
Keywords
Hepatitis, Tenofovir, Viread
Medical subject headings
Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAFDrug

    Also called Vemlidy®, GS-7340

    25 mg tablet administered orally once daily

  • TDFDrug

    Also called Viread®

    300 mg tablet administered orally once daily

  • TAF PlaceboDrug

    Tablet administered orally once daily

  • TDF PlaceboDrug

    Tablet administered orally once daily

Study groups in NCT01940471
Study groupRoleWhat they receive
TAF 25 mgExperimentalTAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
Receives: Drug: TAF; Drug: TDF Placebo
TDF 300 mgActive comparatorTDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
Receives: Drug: TDF; Drug: TAF Placebo
Open-label TAFExperimentalAll participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study. After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.
Receives: Drug: TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48

    Measured: Week 48

Secondary outcomes (4)

  1. Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48

    Measured: Week 48

  2. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

    Measured: Baseline, Week 48

  3. Percent Change From Baseline in Spine BMD at Week 48

    Measured: Baseline, Week 48

  4. Change From Baseline at Week 48 in Serum Creatinine

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2013 (estimated)
  2. Study start11 Sep 2013
  3. Primary completion16 Nov 2015
  4. Study completion13 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
875 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940471
Sponsor's protocol ID
GS-US-320-0110
Other IDs
2013-000636-10
Status last verified
Sep 2023
First submitted
20 Aug 2013
Last updated
10 Oct 2023
Data monitoring committee
Yes
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

Publications

  • Buti M, Lim YS, Chan HLY, Agarwal K, Marcellin P, Brunetto MR, Chuang WL, Janssen HLA, Fung SK, Izumi N, Jablkowski MS, Abdurakhmanov D, Abramov F, Wang H, Botros I, Yee LJ, Mateo R, Flaherty JF, Osinusi A, Pan CQ, Shalimar X, Seto WK, Gane EJ. Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials. Aliment Pharmacol Ther. 2024 Dec;60(11-12):1573-1586. doi: 10.1111/apt.18278. Epub 2024 Sep 27.

    PubMed 39327857

  • Lim YS, Chan HLY, Ahn SH, Seto WK, Ning Q, Agarwal K, Janssen HLA, Pan CQ, Chuang WL, Izumi N, Fung S, Shalimar, Brunetto M, Hui AJ, Chang TT, Lim SG, Abramov F, Flaherty JF, Wang H, Yee LJ, Kao JH, Gane E, Hou J, Buti M. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B. JHEP Rep. 2023 Jul 13;5(10):100847. doi: 10.1016/j.jhepr.2023.100847. eCollection 2023 Oct.

    PubMed 37771546

  • Chan HLY, Buti M, Lim YS, Agarwal K, Marcellin P, Brunetto M, Chuang WL, Janssen HLA, Fung S, Izumi N, Abdurakhmanov D, Jablkowski M, Celen MK, Ma X, Caruntu F, Flaherty JF, Abramov F, Wang H, Camus G, Osinusi A, Pan CQ, Shalimar, Seto WK, Gane E; GS-US-320-0110 and GS-US-320-0108 investigators. Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety. Am J Gastroenterol. 2024 Mar 1;119(3):486-496. doi: 10.14309/ajg.0000000000002468. Epub 2023 Aug 9.

    PubMed 37561058

  • Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, Shalimar, Buti M, Cox S, Parhy B, Zhou E, Martin R, Chang S, Lin L, Flaherty JF, Kitrinos KM, Gaggar A, Izumi N, Lim YS. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

    PubMed 30038044

  • Seto WK, Asahina Y, Brown TT, Peng CY, Stanciu C, Abdurakhmanov D, Tabak F, Nguyen TT, Chuang WL, Inokuma T, Ikeda F, Santantonio TA, Habersetzer F, Ramji A, Lau AH, Suri V, Flaherty JF, Wang H, Gaggar A, Subramanian GM, Mukewar S, Brunetto MR, Fung S, Chan HL. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol. 2018 Jun 20:S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. Online ahead of print.

    PubMed 29933096

  • Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Celen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.

    PubMed 29756595

  • Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.

    PubMed 28404091

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAF and TDF in people with HBeAg-positive Chronic Hepatitis B, run by Gilead Sciences at 160 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in South Korea, India, Japan, United States, Canada and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940471, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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