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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

Primary Purpose

HBeAg-negative 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-negative 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

  • Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following:

    • HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening
    • Screening HBV DNA ≥ 2 x 10^4 IU/mL
    • Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN)
  • Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment 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

  • Asian Pacific Liver Center
  • Stanford University Medical Center
  • Huntington Medical Research Institutes
  • Research and Education, Inc.
  • University California San Francisco (UCSF)
  • Silicon Valley Research Institute
  • University of Miami
  • Digestive Disease Associates, PA
  • Henry Ford Health System
  • ID Care
  • Sing Chan Private Practice
  • New Discovery, LLC
  • Xiaoli Ma, PC
  • Hunter Holmes McGuire VA DVMC
  • Monash Medical Centre
  • St. Vincent's Hospital
  • Royal Melbourne Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • University of Calgary
  • Zeidler Ledcor Centre Division of Gastroenterology
  • 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
  • Toronto General Hospital
  • Inspiration Research Limited
  • Toronto Liver Centre
  • Hôpital de la Croix Rousse
  • Hopital Civil de Strasbourg- CHU Service
  • Queen Mary Hospital
  • Princess Margaret Hospital
  • Prince of Wales Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Global Hospitals
  • Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
  • All India Institute of Medical Sciences
  • Nirmal Hospital
  • Seth GS Medical College and KEM Hospital
  • Global Hospital Super Specialty & Transplant Centre
  • S. R Kalla Memorial Gastro & General Hospital
  • Institute of Post Graduate Medical Education And Research
  • Postgraduate Institute of Medical Education and Research
  • Institute of Liver and Biliary Sciences
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliera S. Orsola - Malpighi
  • Azienda Ospedaliero Universitaria Ospedali
  • Azienda Ospedaliero- Universitaria Pisana
  • Kurume University Hospital
  • Kyushu University Hospital Fukuoka
  • National Hospital Organization Nagasaki Medical Center
  • Osaka University Hospital
  • Shin-Kokura Hospital
  • Kobe City Medical Center General Hospital
  • Japan Red Cross Musashino Hospital
  • The Hospital of Hyogo College of Medicine
  • Osaka Red Cross Hospital
  • Hokkaido University Hospital
  • Medical Hospital of Tokyo Medical and Dental University
  • Pusan National University Yangsan Hospital
  • Kyungpook National University Hospital
  • Keimyung University Dongsan Medical Center
  • Yonsei University, Severance Hospital
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Samsung Medical Center
  • Seoul Saint Mary Hospital
  • Chung-Ang University Hospital
  • Korea University Guro Hospital
  • Auckland Clinical Studies Limited
  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
  • Szpital Specjalistyczny w Chorzowie Oddział
  • SPZOZ, Wojewódzki Specjalistyczny Szpital
  • Centrum Badan Klinicznych - Przychodnia Badan
  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • 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
  • Infection Center LLC Building 20, MSH #163 Territory Koltsovo
  • 1st Moscow State Medical University University Clinical Hospital #3
  • Limited Liability Company "Modern Medicine Clinic"
  • Infectious Clinical Hospital #1 of Moscow Healthcare Department
  • Novosibirsk State Medical University
  • State Novosibirsk Regional Clinical Hospital
  • Scientific Research Institute of Clinical Immunology
  • Clinical Infectious Hospital named after S.P.Botkin
  • Kirov Medical Military Academy
  • Research Institute of Influenza
  • Hospital Universitari Vall d'Hebron
  • Hualien Tzu Chi Hospital
  • Kaohsiung Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Dicle University Medical Faculty Department of Infectious Diseases
  • Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
  • Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji
  • Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi
  • Ege Universitesi Tip Fakultesi Hastanesi
  • Nottingham University Hospitals NHS Trust
  • Barts and The London NHS Trust Royal London Hospital
  • King's College Hospital

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

Secondary Outcome Measures

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 in Serum Creatinine at Week 48

Full Information

First Posted
August 20, 2013
Last Updated
September 22, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01940341
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2013 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
August 31, 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)-negative chronic hepatitis B virus (HBV) infection.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HBeAg-negative 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
426 (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
Description
The primary efficacy endpoint was determined by the achievement of HBV DNA < 29 IU/mL at Week 48.
Time Frame
Week 48
Secondary Outcome Measure Information:
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 in Serum Creatinine at Week 48
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. Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following: HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening. Screening HBV DNA ≥ 2 x 10^4 IU/mL. Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN). Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment 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). 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
Asian Pacific Liver Center
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
University California San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
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
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
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
Xiaoli Ma, PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Hunter Holmes McGuire VA DVMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
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
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
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
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 1H3
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
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
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
Hôpital de la Croix Rousse
City
Lyon cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Hopital Civil de Strasbourg- CHU Service
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong SAR
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Kwai Chung
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong
Facility Name
Global Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500004
Country
India
Facility Name
Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500058
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Nirmal Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Seth GS Medical College and KEM Hospital
City
Mumbai
State/Province
Maharastra
ZIP/Postal Code
400012
Country
India
Facility Name
Global Hospital Super Specialty & Transplant Centre
City
Parel
State/Province
Mumbai
ZIP/Postal Code
400 012
Country
India
Facility Name
S. R Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
Institute of Post Graduate Medical Education And Research
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Azienda Ospedaliero- Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kyushu University Hospital Fukuoka
City
Fukuoka
State/Province
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Omura-shi
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Shin-Kokura Hospital
City
Kitakyushu
ZIP/Postal Code
803-8505
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Japan Red Cross Musashino Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
ZIP/Postal Code
543-8555
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
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Yonsei University, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul Saint Mary Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Auckland Clinical Studies Limited
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Szpital Specjalistyczny w Chorzowie Oddział
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
Centrum Badan Klinicznych - Przychodnia Badan
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
City
Bucuresti
ZIP/Postal Code
21105
Country
Romania
Facility Name
Spitatul Clinic de Boli Infectioase Constanta
City
Constanta
ZIP/Postal Code
900708
Country
Romania
Facility Name
Gastromedica SRL
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Infection Center LLC Building 20, MSH #163 Territory Koltsovo
City
Koltsovo
State/Province
Novosibirsk
ZIP/Postal Code
630559
Country
Russian Federation
Facility Name
1st Moscow State Medical University University Clinical Hospital #3
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Limited Liability Company "Modern Medicine Clinic"
City
Moscow
ZIP/Postal Code
121293
Country
Russian Federation
Facility Name
Infectious Clinical Hospital #1 of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630084
Country
Russian Federation
Facility Name
State Novosibirsk Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Scientific Research Institute of Clinical Immunology
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Clinical Infectious Hospital named after S.P.Botkin
City
Saint-Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Facility Name
Kirov Medical Military Academy
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Research Institute of Influenza
City
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Dicle University Medical Faculty Department of Infectious Diseases
City
Diyarbakir
State/Province
Diyarbakri
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Barts and The London NHS Trust Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
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
28404092
Citation
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. Erratum In: Lancet Gastroenterol Hepatol. 2016 Nov;1(3):e2.
Results Reference
derived
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-320-0108
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 Negative for Hepatitis B e Antigen

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