Study Details

OVERVIEW

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

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

HBeAg-positive Chronic Hepatitis B

Gender

N/A

Date

September 2013 - November 2015

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

TAF, TDF, TAF Placebo, TDF Placebo

Eligibility Information

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).

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.

Locations

Locations (160)

Coalition of Inclusive Medicine

Los Angeles, California, United States, 90020

Stanford University Medical Center

Palo Alto, California, United States, 94304

Huntington Medical Research Institutes

Pasadena, California, United States, 91105

Research and Education, Inc.

San Diego, California, United States, 92105

Silicon Valley Research Institute

San Jose, California, United States, 95128

University of Miami

Miami, Florida, United States, 33136

Digestive Disease Associates, PA

Catonsville, Maryland, United States, 21228

Tufts Medical Center, Inc

Boston, Massachusetts, United States, 02111

Henry Ford Health System

Detroit, Michigan, United States, 48202

Sing Chan Private Practice

Flushing, New York, United States, 11354

New Discovery, LLC

Flushing, New York, United States, 11355

Jefferson Medical College

Philadelphia, Pennsylvania, United States, 19107

Xiaoli Ma, PC

Philadelphia, Pennsylvania, United States, 19107

Texas Clinical Research Institute, LLC

Arlington, Texas, United States, 76012

Kelsey Research Foundation

Houston, Texas, United States, 77005

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Concord Repatriation General Hospital

Concord, New South Wales, Australia, 2137

Westmead Hospital Westmead

Westmead, New South Wales, Australia, 2145

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Monash Medical Centre

Clayton, Victoria, Australia, 3168

St. Vincent's Hospital

Fitzroy, Victoria, Australia, 3065

Footscray Hospital

Footscray, Victoria, Australia, 3011

Austin Health

Heidelberg, Victoria, Australia, 3084

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Tokuda Hospital - Sofia

Sofia, Bulgaria, 1407

MHAT Alexandrovska Medical University, Sofia

Sofia, Bulgaria, 1431

MMA Hospital of Active Treatment

Sofia, Bulgaria, 1606

MHAT Sofia Med

Sofia, Bulgaria, 1797

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine

Edmonton, Alberta, Canada, T6G 2X8

Liver and Intestinal Research Centre

Vancouver, British Columbia, Canada, V5Z 1H2

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada, V5Z 1M9

Dr. John Farley, Inc.

Vancouver, British Columbia, Canada, V6A 4B6

Vancouver Infectious Disease Research and Care Centre

Vancouver, British Columbia, Canada, V6Z 2C7

Gastrointestinal Research Institute (GIRI)

Vancouver, British Columbia, Canada, V6Z 2K5

University of Manitoba, Health Sciences Center

Winnipeg, Manitoba, Canada, R3E 3P4

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

University Health Network / Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Inspiration Research Limited

Toronto, Ontario, Canada, M5T 2S8

Toronto Liver Centre

Toronto, Ontario, Canada, M6H 3M1

Hopital Beaujon

Clichy, France, 92110

Hopital Pitie Salpetriere

Paris, France, 75651

Hopital Civil de Strasbourg

Strasbourg, France, 67091

Hopital Paul Brousse

Villejuif, France, 94804

Queen Mary Hospital

Hong Kong, Hong Kong

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Prince of Wales Hospital

Sha Tin, Hong Kong

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Tuen Mun Hospital

Tuen Mun, Hong Kong

BYL Nair Hospital & T N Medical College

Mumbai, Maharashtra, India, 400008

Government Medical College and Superspecialty Hospital

Nagpur, Maharashtra, India, 440003

Midas Multispecialty Hospital

Nagpur, Maharashtra, India, 440010

SMS Medical College & Hospital

Jaipur, Rajasthan, India, 302004

Postgraduate Institute of Medical Education & Research

Chandigarh, India, 160012

YR Gaitonde Centre for AIDS Research and Education

Chennai, India, 600113

VGM Hospital

Coimbatore, India, 641005

Gleneagles Global Hospital

Hyderabad, India, 500004

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

Hyderabad, India, 500058

S. R Kalla Memorial Gastro & General Hospital

Jaipur, India, 302001

Peerless Hospital & B.K.Roy Research Center

Kolkata, India, 700 094

Postgraduate Institute of Medical Education & Research

Kolkata, India, 700020

Seth GS Medical College and KEM Hospital

Mumbai, India, 400012

All India Institute of Medical Sciences

New Delhi, India, 110029

Sir Ganga Ram Hospital

New Delhi, India, 110060

Institute of Liver and Biliary Sciences

New Delhi, India, 110070

Global Hospital Super Specialty & Transplant Centre

Parel, India, 400 012

Nirmal Hospital

Surat, India, 395002

Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

Bologna, Italy, 40138

Istituto Europeo di Oncologia

Bologna, Italy, 40138

Azienda Ospedaliero Universitaria Ospedali Riuniti di

Foggia, Italy, 71100

Policlinico Universitario G. Martino via Consolare

Messina, Italy, 98124

Azienda Ospedale San Paolo

Milano, Italy, 20142

Azienda Ospedaliera di Padova

Padova, Italy, 35100

Azienda Ospedaliera di Padova

Padova, Italy, 35121

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, 56124

Kyushu University Hospital

Fukuoka, Fukuoka-shi, Japan, 812-8582

Shin-Kokura Hospital

Fukuoka, Japan, 803-8505

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan, 810-8563

Kagawa Prefectural Central Hospital

Kagawa, Japan, 760-8557

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Yamanashi Prefectural Central Hospital

Kofu, Japan, 400-8506

Kurume University Hospital

Kurume, Japan, 830-0011

Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566

Japan Red Cross Musashino Hospital

Musashino, Japan, 180-8610

Hyogo College of Medicine

Nishinomiya, Japan, 663-8501

Okayama University Hospital

Okayama, Japan, 700-8558

National Hospital Organization Nagasaki Medical Center

Omura, Japan, 856-8562

Osaka Red Cross Hospital

Osaka, Japan, 543-8555

Osaka University Hospital

Osaka, Japan, 545-8586

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Medical Hospital of Tokyo Medical and Dental University

Tokyo, Japan, 113-8519

Kosin University College of Medicine

Busan, Seo-gu, Korea, Republic of, 602702

Pusan National University Hospital

Busan, Korea, Republic of, 602-739

SoonChunHyang University Hospital Cheonan

Cheonan, Korea, Republic of, 330-721

Keimyung University Dongsan Medical Center

Daegu, Korea, Republic of, 700-712

Kyungpook National University Hospital

Daegu, Korea, Republic of, 700-721

Konyang University Hospital

Daejeon, Korea, Republic of, 302-718

Inje University Ilsan Paik Hospital

Gyeonggi-do, Korea, Republic of, 411-706

Ajou University Hospital

Gyeonggi-do, Korea, Republic of, 443-380

Seoul National University Bundang Hospital

Gyeonggi-Do, Korea, Republic of, 463-707

Seoul National University Hospital

Seoul, Korea, Republic of, 110-744

Severance Hospital Yonsei University Health System

Seoul, Korea, Republic of, 120-752

Samsung Medical Center

Seoul, Korea, Republic of, 135-710

Gangnam Severance Hospital

Seoul, Korea, Republic of, 135-720

Seoul Saint Mary Hospital

Seoul, Korea, Republic of, 137-701

Asan Medical Center

Seoul, Korea, Republic of, 138-736

Konkuk University Medical Center

Seoul, Korea, Republic of, 143-729

Korea University Guro Hospital

Seoul, Korea, Republic of, 152-703

SMG-SNU Boramae Medical Center

Seoul, Korea, Republic of, 156-707

Chung-Ang University Hospital

Seoul, Korea, Republic of, 156-755

Ulsan University Hospital

Ulsan, Korea, Republic of, 682-714

Yonsei Unversity Wonju

Wŏnju, Korea, Republic of, 220-701

Pusan National University Yangsan Hospital

Yangsan, Korea, Republic of, 626-770

Auckland Clinical Studies Limited

Auckland, New Zealand, 1142

Waikato Hospital (District Health Board)

Hamilton, New Zealand, 2001

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

Bialystok, Poland, 15-540

Szpital Specjalistyczny

Chorzow, Poland, 41-500

SPZOZ, Wojewódzki Specjalistyczny Szpital

Lodz, Poland, 91-347

SP ZOZ Wojewódzki Szpital Zakazny

Warszawa, Poland, 01-201

Centrum Badan Klinicznych

Wroclaw, Poland, 50-349

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

Bucharest, Romania, 030303

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

Bucuresti, Romania, 021105

Spitatul Clinic de Boli Infectioase Constanta

Constanţa, Romania, 900709

Gastromedica SRL

Iasi, Romania, 700506

Spitalul Clinic Judetean de Urgenta Timisoara

Timişoara, Romania, 300736

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

Lipetsk, Russian Federation, 398043

Scientific Research Institute of Nutrition

Moscow, Russian Federation, 115446

People's Friendship University of Russia

Moscow, Russian Federation, 117198

1st Moscow State Medical University University Clinical Hospital #3

Moscow, Russian Federation, 119435

Limited Liability Company "Modern Medicine Clinic"

Moscow, Russian Federation, 121170

Institute of Clinical Immunology RAMS, Clinic of Immunopathology

Novosibirsk, Russian Federation, 630084

Scientific Research Institute of Clinical Immunology

Novosibirsk, Russian Federation, 630099

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

Saint-Petersburg, Russian Federation, 191167

Research Institute of Influenza

Saint-Petersburg, Russian Federation, 197376

Medical Company Hepatology

Samara, Russian Federation, 443063

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Russian Federation, 620102

National University Hospital Singapore

Singapore, Singapore, 119228

Singapore General Hospital

Singapore, Singapore, 169608

Changi General Hospital Pte Ltd.

Singapore, Singapore, 529889

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 4103

Chiayi Christian Hospital

Chiayi, Taiwan, 60002

Hualien Tzu Chi Medical Center

Hualien, Taiwan, 970

Kaohsiung Med. College Hosp. Dept. of Internal Medicine

Kaohsiung, Taiwan, 80756

China Medical University Hospital

Taichung, Taiwan, 404

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

National Taiwan University Hospital

Taipei, Taiwan, 10002

Cathay General Hospital

Taipei, Taiwan, 10630

Far-Eastern Memorial Hospital

Taipei, Taiwan, 220

Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

Ankara, Turkey, 06100

University of Uludag

Bursa, Turkey, 16059

Dicle University Medical Faculty Department of Infectious Diseases

Diyarbakir, Turkey, 21280

Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon

Istanbul, Turkey, 34098

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey, 35100

Barts & The London NHS Trust

London, United Kingdom, E1 1BB

Royal Free Hospital

London, United Kingdom, NW3 2QG

King's College Hospital

London, United Kingdom, SE5 9RS

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG7 2UH

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (160)

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