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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

Primary Purpose

HBeAg-positive Chronic Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAF
TDF
TAF Placebo
TDF Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HBeAg-positive Chronic Hepatitis B focused on measuring Hepatitis, Tenofovir, Viread

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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, 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.

Sites / Locations

  • Coalition of Inclusive Medicine
  • Stanford University Medical Center
  • Huntington Medical Research Institutes
  • Research and Education, Inc.
  • Silicon Valley Research Institute
  • University of Miami
  • Digestive Disease Associates, PA
  • Tufts Medical Center, Inc
  • Henry Ford Health System
  • Sing Chan Private Practice
  • New Discovery, LLC
  • Jefferson Medical College
  • Xiaoli Ma, PC
  • Texas Clinical Research Institute, LLC
  • Kelsey Research Foundation
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • Westmead Hospital Westmead
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • St. Vincent's Hospital
  • Footscray Hospital
  • Austin Health
  • The Alfred Hospital
  • The Royal Melbourne Hospital
  • Royal Perth Hospital
  • Tokuda Hospital - Sofia
  • MHAT Alexandrovska Medical University, Sofia
  • MMA Hospital of Active Treatment
  • MHAT Sofia Med
  • University of Calgary
  • Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine
  • Liver and Intestinal Research Centre
  • Gordon and Leslie Diamond Health Care Centre
  • Dr. John Farley, Inc.
  • Vancouver Infectious Disease Research and Care Centre
  • Gastrointestinal Research Institute (GIRI)
  • University of Manitoba, Health Sciences Center
  • The Ottawa Hospital
  • University Health Network / Toronto General Hospital
  • Inspiration Research Limited
  • Toronto Liver Centre
  • Hopital Beaujon
  • Hopital Pitie Salpetriere
  • Hopital Civil de Strasbourg
  • Hopital Paul Brousse
  • Queen Mary Hospital
  • Princess Margaret Hospital
  • Prince of Wales Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Tuen Mun Hospital
  • BYL Nair Hospital & T N Medical College
  • Government Medical College and Superspecialty Hospital
  • Midas Multispecialty Hospital
  • SMS Medical College & Hospital
  • Postgraduate Institute of Medical Education & Research
  • YR Gaitonde Centre for AIDS Research and Education
  • VGM Hospital
  • Gleneagles Global Hospital
  • Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
  • S. R Kalla Memorial Gastro & General Hospital
  • Peerless Hospital & B.K.Roy Research Center
  • Postgraduate Institute of Medical Education & Research
  • Seth GS Medical College and KEM Hospital
  • All India Institute of Medical Sciences
  • Sir Ganga Ram Hospital
  • Institute of Liver and Biliary Sciences
  • Global Hospital Super Specialty & Transplant Centre
  • Nirmal Hospital
  • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
  • Istituto Europeo di Oncologia
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di
  • Policlinico Universitario G. Martino via Consolare
  • Azienda Ospedale San Paolo
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliero Universitaria Pisana
  • Kyushu University Hospital
  • Shin-Kokura Hospital
  • National Hospital Organization Kyushu Medical Center
  • Kagawa Prefectural Central Hospital
  • Kobe City Medical Center General Hospital
  • Yamanashi Prefectural Central Hospital
  • Kurume University Hospital
  • Kyoto Prefectural University of Medicine
  • Japan Red Cross Musashino Hospital
  • Hyogo College of Medicine
  • Okayama University Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Osaka Red Cross Hospital
  • Osaka University Hospital
  • Hokkaido University Hospital
  • Medical Hospital of Tokyo Medical and Dental University
  • Kosin University College of Medicine
  • Pusan National University Hospital
  • SoonChunHyang University Hospital Cheonan
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Konyang University Hospital
  • Inje University Ilsan Paik Hospital
  • Ajou University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • Samsung Medical Center
  • Gangnam Severance Hospital
  • Seoul Saint Mary Hospital
  • Asan Medical Center
  • Konkuk University Medical Center
  • Korea University Guro Hospital
  • SMG-SNU Boramae Medical Center
  • Chung-Ang University Hospital
  • Ulsan University Hospital
  • Yonsei Unversity Wonju
  • Pusan National University Yangsan Hospital
  • Auckland Clinical Studies Limited
  • Waikato Hospital (District Health Board)
  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
  • Szpital Specjalistyczny
  • SPZOZ, Wojewódzki Specjalistyczny Szpital
  • SP ZOZ Wojewódzki Szpital Zakazny
  • Centrum Badan Klinicznych
  • Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • Spitatul Clinic de Boli Infectioase Constanta
  • Gastromedica SRL
  • Spitalul Clinic Judetean de Urgenta Timisoara
  • Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
  • Scientific Research Institute of Nutrition
  • People's Friendship University of Russia
  • 1st Moscow State Medical University University Clinical Hospital #3
  • Limited Liability Company "Modern Medicine Clinic"
  • Institute of Clinical Immunology RAMS, Clinic of Immunopathology
  • Scientific Research Institute of Clinical Immunology
  • Municipal Clinical Hospital n.a. S.P. Botkin
  • Research Institute of Influenza
  • Medical Company Hepatology
  • Sverdlovsk Regional Clinical Hospital #1
  • National University Hospital Singapore
  • Singapore General Hospital
  • Changi General Hospital Pte Ltd.
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Virgen del Rocio
  • Chiayi Christian Hospital
  • Hualien Tzu Chi Medical Center
  • Kaohsiung Med. College Hosp. Dept. of Internal Medicine
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Cathay General Hospital
  • Far-Eastern Memorial Hospital
  • Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
  • University of Uludag
  • Dicle University Medical Faculty Department of Infectious Diseases
  • Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon
  • Ege Universitesi Tip Fakultesi Hastanesi
  • Barts & The London NHS Trust
  • Royal Free Hospital
  • King's College Hospital
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

TAF 25 mg

TDF 300 mg

Open-label TAF

Arm Description

TAF + TDF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).

TDF + TAF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2013
Last Updated
September 21, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01940471
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2013 (Actual)
Primary Completion Date
November 16, 2015 (Actual)
Study Completion Date
October 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HBeAg-positive Chronic Hepatitis B
Keywords
Hepatitis, Tenofovir, Viread

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
875 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAF 25 mg
Arm Type
Experimental
Arm Description
TAF + TDF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).
Arm Title
TDF 300 mg
Arm Type
Active Comparator
Arm Description
TDF + TAF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).
Arm Title
Open-label TAF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAF
Other Intervention Name(s)
Vemlidy®, GS-7340
Intervention Description
25 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
TDF
Other Intervention Name(s)
Viread®
Intervention Description
300 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
TAF Placebo
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
TDF Placebo
Intervention Description
Tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48
Time Frame
Week 48
Title
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Time Frame
Baseline, Week 48
Title
Percent Change From Baseline in Spine BMD at Week 48
Time Frame
Baseline, Week 48
Title
Change From Baseline at Week 48 in Serum Creatinine
Time Frame
Baseline, Week 48
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Description
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.
Time Frame
Up to 48 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.gileadclinicaltrials.com/transparency-policy/
Citations:
PubMed Identifier
30038044
Citation
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.
Results Reference
derived
PubMed Identifier
29933096
Citation
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.
Results Reference
derived
PubMed Identifier
29756595
Citation
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.
Results Reference
derived
PubMed Identifier
28404091
Citation
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.
Results Reference
derived
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-320-0110
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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