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HBeAg-negative Chronic Hepatitis BPhase 3NCT01940341

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

A Phase 3 study testing TAF and TDF in people with HBeAg-negative Chronic Hepatitis B, run by Gilead Sciences at 105 sites in 17 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)-negative 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-negative 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
426 participants
Where
105 sitesin 17 countries
Study dates
12 Sep 2013to 31 Aug 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.
  • 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.
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 Baseline.
  • 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

105 sites in 17 countries.

105 sites in 17 countries

United States14 sites

  • 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

  • ID Care

    Hillsborough, New Jersey, 08844

  • Asian Pacific Liver Center

    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

  • Xiaoli Ma, PC

    Philadelphia, Pennsylvania, 19107

  • Hunter Holmes McGuire VA DVMC

    Richmond, Virginia, 23249

  • Research and Education, Inc.

    San Diego, California, 92105

  • University California San Francisco (UCSF)

    San Francisco, California, 94110

  • Silicon Valley Research Institute

    San Jose, California, 95128

Other trials in United States

Canada11 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Zeidler Ledcor Centre Division of Gastroenterology

    Edmonton, Alberta, T6G 2X8

  • 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 1H3

  • 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

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Japan11 sites

  • Kyushu University Hospital Fukuoka

    Fukuoka, Fukuoka-shi, 812-8582

  • Shin-Kokura Hospital

    Kitakyushu, 803-8505

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Japan Red Cross Musashino Hospital

    Musashino, 180-8610

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501

  • National Hospital Organization Nagasaki Medical Center

    Omura-shi, Nagasaki, 856-8562

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Medical Hospital of Tokyo Medical and Dental University

    Tokyo, 113-8519

Other trials in Japan

India10 sites

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012

  • Global Hospitals

    Hyderabad, Andhra Pradesh, 500004

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

    Hyderabad, Andhra Pradesh, 500058

  • S. R Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • Institute of Post Graduate Medical Education And Research

    Kolkata, West Bengal, 700020

  • Seth GS Medical College and KEM Hospital

    Mumbai, Maharashtra, 400012

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Institute of Liver and Biliary Sciences

    New Delhi, 110070

  • Global Hospital Super Specialty & Transplant Centre

    Parel, Mumbai, 400 012

  • Nirmal Hospital

    Surat, Gujarat, 395002

Other trials in India

Russia10 sites

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

    Kol'tsovo, Novosibirsk Oblast, 630559

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

    Moscow, 119991

  • Limited Liability Company "Modern Medicine Clinic"

    Moscow, 121293

  • Infectious Clinical Hospital #1 of Moscow Healthcare Department

    Moscow, 125367

  • Novosibirsk State Medical University

    Novosibirsk, 630084

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

  • Scientific Research Institute of Clinical Immunology

    Novosibirsk, 630091

  • Clinical Infectious Hospital named after S.P.Botkin

    Saint Petersburg, 191167

  • Kirov Medical Military Academy

    Saint Petersburg, 194044

  • Research Institute of Influenza

    Saint Petersburg, 197376

Other trials in Russia

South Korea10 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • Yonsei University, Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Seoul Saint Mary Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Korea University Guro Hospital

    Seoul, 08308

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Australia5 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

Romania5 sites

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

    Bucharest, Bucharest, 021105

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

    Bucharest, 030303

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

    Bucharest, 21105

  • Spitatul Clinic de Boli Infectioase Constanta

    Constanța, 900708

  • Gastromedica SRL

    Iași, 700506

Other trials in Romania

Taiwan5 sites

  • Hualien Tzu Chi Hospital

    Hualien City, 970

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

    Ankara, 06590

  • Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji

    Bursa, 16059

  • Dicle University Medical Faculty Department of Infectious Diseases

    Diyarbakır, Diyarbakri, 21280

  • Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi

    Istanbul, 34098

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35040

Other trials in Turkey (Türkiye)

Hong Kong4 sites

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR

  • Princess Margaret Hospital

    Kwai Chung

  • Prince of Wales Hospital

    Shatin

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po

Other trials in Hong Kong

Italy4 sites

  • Azienda Ospedaliera S. Orsola - Malpighi

    Bologna, 40138

  • Azienda Ospedaliero Universitaria Ospedali

    Foggia, 71122

  • Azienda Ospedaliero- Universitaria Pisana

    Pisa, 56124

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Poland4 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

    Bialystok, 15-540

  • Szpital Specjalistyczny w Chorzowie Oddział

    Chorzów, 41-500

  • SPZOZ, Wojewódzki Specjalistyczny Szpital

    Lodz, 91-347

  • Centrum Badan Klinicznych - Przychodnia Badan

    Wroclaw, 50-349

Other trials in Poland

United Kingdom3 sites

  • Barts and The London NHS Trust Royal London Hospital

    London, E1 1BB

  • King's College Hospital

    London, SE5 9RS

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

France2 sites

  • Hôpital de la Croix Rousse

    Lyon, 69317

  • Hopital Civil de Strasbourg- CHU Service

    Strasbourg, 67000

Other trials in France

New Zealand1 site

  • Auckland Clinical Studies Limited

    Auckland, 1010

Other trials in New Zealand

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

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-Negative, 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)-negative chronic hepatitis B virus (HBV) infection.

Read the detailed 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.

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 NCT01940341
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

    The primary efficacy endpoint was determined by the achievement of HBV DNA < 29 IU/mL at Week 48.

    Measured: Week 48

Secondary outcomes (3)

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

    Measured: Baseline, Week 48

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

    Measured: Baseline, Week 48

  3. Change From Baseline in Serum Creatinine at Week 48

    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 start12 Sep 2013
  3. Primary completion30 Sep 2015
  4. Study completion31 Aug 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
426 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940341
Sponsor's protocol ID
GS-US-320-0108
Other IDs
2013-000626-63
Status last verified
Sep 2023
First submitted
20 Aug 2013
Last updated
25 Sep 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

  • Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.

    PubMed 28404092

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAF and TDF in people with HBeAg-negative Chronic Hepatitis B, run by Gilead Sciences at 105 sites in 17 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 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Canada, Japan, India, Russia and 12 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 (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 NCT01940341, 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 25 Sep 2023.

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