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, 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.

Study Overview

• Status: Completed
• Conditions: HBeAg-positive Chronic Hepatitis B
• Intervention / Treatment: Drug: TAF; Drug: TDF Placebo; Drug: TDF; Drug: TAF Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 875
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Concord, New South Wales, Australia, 2137
      • Concord Repatriation General Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital Westmead
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Fitzroy, Victoria, Australia, 3065
      • St. Vincent's Hospital
    • Footscray, Victoria, Australia, 3011
      • Footscray Hospital
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Bulgaria
  • Sofia, Bulgaria, 1407
    • Tokuda Hospital - Sofia
  • Sofia, Bulgaria, 1431
    • MHAT Alexandrovska Medical University, Sofia
  • Sofia, Bulgaria, 1606
    • MMA Hospital of Active Treatment
  • Sofia, Bulgaria, 1797
    • MHAT Sofia Med
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2X8
      • Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1H2
      • Liver and Intestinal Research Centre
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Gordon and Leslie Diamond Health Care Centre
    • Vancouver, British Columbia, Canada, V6A 4B6
      • Dr. John Farley, Inc.
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver Infectious Disease Research and Care Centre
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Gastrointestinal Research Institute (GIRI)
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • University of Manitoba, Health Sciences Center
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network / Toronto General Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Inspiration Research Limited
    • Toronto, Ontario, Canada, M6H 3M1
      • Toronto Liver Centre
• France
  • Clichy, France, 92110
    • Hopital Beaujon
  • Paris, France, 75651
    • Hopital Pitie Salpetriere
  • Strasbourg, France, 67091
    • Hopital Civil de strasbourg
  • Villejuif, France, 94804
    • Hopital Paul Brousse
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Lai Chi Kok, Hong Kong
    • Princess Margaret Hospital
  • Sha Tin, Hong Kong
    • Prince of Wales Hospital
  • Tai Po, Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital
  • Tuen Mun, Hong Kong
    • Tuen Mun Hospital
• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education & Research
  • Chennai, India, 600113
    • YR Gaitonde Centre for AIDS Research and Education
  • Coimbatore, India, 641005
    • VGM Hospital
  • Hyderabad, India, 500004
    • Gleneagles Global Hospital
  • Hyderabad, India, 500058
    • Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
  • Jaipur, India, 302001
    • S. R Kalla Memorial Gastro & General Hospital
  • Kolkata, India, 700 094
    • Peerless Hospital & B.K.Roy Research Center
  • Kolkata, India, 700020
    • Postgraduate Institute of Medical Education & Research
  • Mumbai, India, 400012
    • Seth GS medical college and KEM Hospital
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • New Delhi, India, 110070
    • Institute of liver and Biliary Sciences
  • Parel, India, 400 012
    • Global Hospital Super Specialty & Transplant Centre
  • Surat, India, 395002
    • Nirmal Hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
      • BYL Nair Hospital & T N Medical College
    • Nagpur, Maharashtra, India, 440003
      • Government Medical College and Superspecialty Hospital
    • Nagpur, Maharashtra, India, 440010
      • Midas Multispecialty Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302004
      • SMS Medical College & Hospital
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
  • Bologna, Italy, 40138
    • Istituto Europeo di Oncologia
  • Foggia, Italy, 71100
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di
  • Messina, Italy, 98124
    • Policlinico Universitario G. Martino via Consolare
  • Milano, Italy, 20142
    • Azienda Ospedale San Paolo
  • Padova, Italy, 35100
    • Azienda Ospedaliera di Padova
  • Padova, Italy, 35121
    • Azienda Ospedaliera di Padova
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Fukuoka, Japan, 803-8505
    • Shin-Kokura Hospital
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Kagawa, Japan, 760-8557
    • Kagawa Prefectural Central Hospital
  • Kobe, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Kofu, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Kyoto, Japan, 602-8566
    • Kyoto Prefectural University of Medicine
  • Musashino, Japan, 180-8610
    • Japan Red Cross Musashino Hospital
  • Nishinomiya, Japan, 663-8501
    • Hyogo College of Medicine
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Omura, Japan, 856-8562
    • National Hospital Organization Nagasaki Medical Center
  • Osaka, Japan, 543-8555
    • Osaka Red Cross Hospital
  • Osaka, Japan, 545-8586
    • Osaka University Hospital
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Tokyo, Japan, 113-8519
    • Medical Hospital of Tokyo Medical and Dental University
  • Fukuoka-shi
    • Fukuoka, Fukuoka-shi, Japan, 812-8582
      • Kyushu University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Cheonan, Korea, Republic of, 330-721
    • Soonchunhyang University Hospital Cheonan
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of, 302-718
    • Konyang University Hospital
  • Gyeonggi-Do, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of, 411-706
    • Inje University Ilsan Paik Hospital
  • Gyeonggi-do, Korea, Republic of, 443-380
    • Ajou University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 156-755
    • Chung-ang University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 135-720
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 137-701
    • Seoul Saint Mary Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 156-707
    • SMG-SNU Boramae Medical Center
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital
  • Wŏnju, Korea, Republic of, 220-701
    • Yonsei Unversity Wonju
  • Yangsan, Korea, Republic of, 626-770
    • Pusan National University Yangsan Hospital
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of, 602702
      • Kosin University College of Medicine
• New Zealand
  • Auckland, New Zealand, 1142
    • Auckland Clinical Studies Limited
  • Hamilton, New Zealand, 2001
    • Waikato Hospital (District Health Board)
• Poland
  • Bialystok, Poland, 15-540
    • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
  • Chorzow, Poland, 41-500
    • Szpital Specjalistyczny
  • Lodz, Poland, 91-347
    • SPZOZ, Wojewódzki Specjalistyczny Szpital
  • Warszawa, Poland, 01-201
    • SP ZOZ Wojewódzki Szpital Zakazny
  • Wroclaw, Poland, 50-349
    • Centrum Badan Klinicznych
• Romania
  • Bucharest, Romania, 030303
    • Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
  • Bucuresti, Romania, 021105
    • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • Constanţa, Romania, 900709
    • Spitatul Clinic de Boli Infectioase Constanta
  • Iasi, Romania, 700506
    • GastroMedica SRL
  • Timişoara, Romania, 300736
    • Spitalul Clinic Judetean de Urgenta Timisoara
• Russian Federation
  • Lipetsk, Russian Federation, 398043
    • Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
  • Moscow, Russian Federation, 115446
    • Scientific Research Institute of Nutrition
  • Moscow, Russian Federation, 117198
    • People's Friendship University of Russia
  • Moscow, Russian Federation, 119435
    • 1st Moscow State Medical University University Clinical Hospital #3
  • Moscow, Russian Federation, 121170
    • Limited Liability Company "Modern Medicine Clinic"
  • Novosibirsk, Russian Federation, 630084
    • Institute of Clinical Immunology RAMS, Clinic of Immunopathology
  • Novosibirsk, Russian Federation, 630099
    • Scientific Research Institute of Clinical Immunology
  • Saint-Petersburg, Russian Federation, 191167
    • Municipal Clinical Hospital n.a. S.P. Botkin
  • Saint-Petersburg, Russian Federation, 197376
    • Research Institute of Influenza
  • Samara, Russian Federation, 443063
    • Medical Company Hepatology
  • Yekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital Pte Ltd.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Sevilla, Spain, 4103
    • Hospital Universitario Virgen del Rocio
• Taiwan
  • Chiayi, Taiwan, 60002
    • Chiayi Christian Hospital
  • Hualien, Taiwan, 970
    • Hualien Tzu Chi Medical Center
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Med. College Hosp. Dept. of Internal Medicine
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10630
    • Cathay General Hospital
  • Taipei, Taiwan, 220
    • Far-Eastern Memorial Hospital
• Turkey
  • Ankara, Turkey, 06100
    • Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
  • Bursa, Turkey, 16059
    • University of Uludag
  • Diyarbakir, Turkey, 21280
    • Dicle University Medical Faculty Department of Infectious Diseases
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon
  • Izmir, Turkey, 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, E1 1BB
    • Barts & The London NHS Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals NHS Trust
• United States
  • California
    • Los Angeles, California, United States, 90020
      • Coalition of Inclusive Medicine
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • Pasadena, California, United States, 91105
      • Huntington Medical Research Institutes
    • San Diego, California, United States, 92105
      • Research and Education, Inc.
    • San Jose, California, United States, 95128
      • Silicon Valley Research Institute
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Digestive Disease Associates, PA
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center, Inc
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • New York
    • Flushing, New York, United States, 11354
      • Sing Chan Private Practice
    • Flushing, New York, United States, 11355
      • New Discovery, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Medical College
    • Philadelphia, Pennsylvania, United States, 19107
      • Xiaoli Ma, PC
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute, LLC
    • Houston, Texas, United States, 77005
      • Kelsey Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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
  • 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).

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 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAF 25 mg; TAF + TDF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).	Drug: TAF; 25 mg tablet administered orally once daily; Other Names: Vemlidy®; GS-7340; Drug: TDF Placebo; Tablet administered orally once daily
Active Comparator: TDF 300 mg; TDF + TAF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).	Drug: TDF; 300 mg tablet administered orally once daily; Other Names: Viread®; Drug: TAF Placebo; Tablet administered orally once daily
Experimental: Open-label TAF; All 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.	Drug: TAF; 25 mg tablet administered orally once daily; Other Names: Vemlidy®; GS-7340

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48	Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48	Week 48
Percent Change From Baseline in Spine BMD at Week 48	Baseline, Week 48
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48	Baseline, Week 48
Change From Baseline at Week 48 in Serum Creatinine	Baseline, Week 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48	Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Lancet Gastroenterol Hepatol. 2016 Nov;1(3):e2.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2013
• Primary Completion (Actual): November 16, 2015
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimated): September 12, 2013

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Tenofovir; Hepatitis; Viread
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: GS-US-320-0110; 2013-000636-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No