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Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HBV; Chronic HBV Infections

Intervention: Tenofovir alafenamide (Drug); Tenofovir DF (Drug); Placebo to match tenofovir alafenamide (Drug); Placebo to match tenofovir DF (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
John Flaherty, PharmD, Study Director, Affiliation: Gilead Sciences

Overall contact:
Charlene Kranz, Email: TAF4HBV@gilead.com

Summary

The purpose of this study is to evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disoproxil fumarate (TDF) in treatment naive and experienced adult subjects with chronic hepatitis B virus (HBV) infection, as determined by the achievement of HBV DNA < 29 IU/mL at Week 48.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The proportion of participants with hepatitis B virus (HBV) DNA < 29 IU/mL

Secondary outcome:

Percent change from baseline in hip and spine bone mineral density (BMD) at Week 48

Change from baseline in serum creatinine at Week 48

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2. Adult males and non-pregnant, non-lactating females, 18 years of age and older 3. Documented evidence of chronic HBV (CHB) infection 4. 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) 5. 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) 6. Previous treatment with interferon (pegylated or non pegylated) must have ended at least 6 months prior to the baseline visit. 7. Adequate renal function 8. Normal ECG Exclusion Criteria: 1. Females who are breastfeeding 2. Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study 3. Co-infection with hepatitis C, HIV, or hepatitis D 4. Evidence of hepatocellular carcinoma 5. Any clinical and/or laboratory evidence of hepatic decompensation 6. Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN 7. Received solid organ or bone marrow transplant 8. History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; participants under evaluation for possible malignancy are not eligible 9. Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion 10. Subjects receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or subjects with a known hypersensitivity to study drugs, metabolites, or formulation excipients 11. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance 12. 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

Locations and Contacts

Charlene Kranz, Email: TAF4HBV@gilead.com

St. Vincent's Hospital, Fitzroy 3065, Australia; Active, not recruiting

Sir Charles Gairdner Hospital, Nedlands 6009, Australia; Active, not recruiting

Beijing Ditan Hospital, Beijing 100011, China; Not yet recruiting

Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China; Not yet recruiting

Beijing You An Hospital,Capital Medical University, Beijing 100069, China; Not yet recruiting

Peking University First Hospital, Beijing 100034, China; Not yet recruiting

Peking University People's Hospital, Beijing 100044, China; Not yet recruiting

85 Hospital of People's Liberation Army, Shanghai 200052, China; Not yet recruiting

Huashan Hospital, Fudan University, Shanghai 200040, China; Recruiting

Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai 200127, China; Not yet recruiting

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China; Not yet recruiting

Shanghai Public Health Clinical Center, Shanghai 201508, China; Not yet recruiting

Hopital Beaujon, Clichy Cedex 92110, France; Withdrawn

Hopital Pitie Salpetriere, Paris 75013, France; Withdrawn

Hopital Paul Brousse, Villejuif 94800, France; Withdrawn

Queen Mary Hospital, Hong Kong, Hong Kong; Active, not recruiting

Prince of Wales Hospital, Sha Tin, Hong Kong; Active, not recruiting

Alice Ho Miu Ling Nethersole Hospital, Tai Po, Hong Kong; Active, not recruiting

Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India; Active, not recruiting

Coimbatore 641005, India; Withdrawn

Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals, Hyderabad 500058, India; Active, not recruiting

S.R. Kalla Hospital, Jaipur 302001, India; Active, not recruiting

Lucknow 226014, India; Withdrawn

Midas Multispecialty Hospital, Nagpur 440010, India; Withdrawn

All India Institute of Medical Sciences, New Delhi 110029, India; Active, not recruiting

Institute of Liver and Biliary Sciences, New Delhi 110070, India; Active, not recruiting

Nirmal Hospital, Surat 395002, India; Active, not recruiting

Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi, Bologna 40138, Italy; Active, not recruiting

Azienda Ospedaliero Universitaria Pisana, Cisanello Pisa 56124, Italy; Active, not recruiting

Ospedali Riuniti Azienda Ospedaliera Universitaria di Foggia, Foggia 71122, Italy; Active, not recruiting

Azienda Ospedale San Paolo, Milano 20142, Italy; Withdrawn

IRCCS Ospedale Maggiore Policlinico di Milano, Milano 20122, Italy; Withdrawn

Casa Sollievodella Soferrenza IRCCS, San Giovanni Rotondo 71013, Italy; Active, not recruiting

Kyushu University Hospital Fukuoka, Fukuoka-shi 812-8582, Japan; Active, not recruiting

National Hospital Organization Kyushu Medical Center, Fukuoka 810-8563, Japan; Withdrawn

Shin-Kokura Hospital, Fukuoka 803-8505, Japan; Active, not recruiting

Kobe City Medical Center General Hospital, Hyogo 650-0047, Japan; Active, not recruiting

Kohnodai Hospital, National Center for Global Health and Medicine, Ichikawa 272-0827, Japan; Withdrawn

Kagawa Prefectural Central Hospital, Kagawa 760-0017, Japan; Withdrawn

Yamanashi Prefectural Central Hospital, Kofu 400-8506, Japan; Withdrawn

Kurume University Hospital, Kurume 830-0011, Japan; Active, not recruiting

Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan; Withdrawn

Japan Red Cross Musashino Hospital, Musashino 180-8610, Japan; Active, not recruiting

Hyogo College of Medicine, Nishinomiya 663-8501, Japan; Active, not recruiting

Okayama University Hospital, Okayama 700-8558, Japan; Withdrawn

National Hospital Organization Nagasaki Medical Center, Omura 856-8562, Japan; Active, not recruiting

Kinki University Hospital, Osaka 589-8511, Japan; Withdrawn

Osaka Red Cross Hospital, Osaka 543-8555, Japan; Active, not recruiting

Osaka University Hospital, Osaka 545-8586, Japan; Withdrawn

Hokkaido University Hospital, Sapporo 060-8648, Japan; Active, not recruiting

Osaka University Hospital, Suita 565-0871, Japan; Active, not recruiting

Medical Hospital of Tokyo Medical and Dental University, Tokyo 113-8519, Japan; Active, not recruiting

Yamagata University Hospital, Yamagata 990-9585, Japan; Withdrawn

Pusan National University Hospital, Busan 602-739, Korea, Republic of; Withdrawn

Keimyung University Dongsan Medical Center, Daegu 700-712, Korea, Republic of; Active, not recruiting

Kyungpook National University Hospital, Daegu 700-721, Korea, Republic of; Active, not recruiting

Gangnam-gu 135-720, Korea, Republic of; Active, not recruiting

Asan Medical Center, Seoul 138-736, Korea, Republic of; Active, not recruiting

Korea University Guro Hospital, Seoul 152-703, Korea, Republic of; Active, not recruiting

Samsung Medical Center, Seoul 135-710, Korea, Republic of; Active, not recruiting

Seoul Saint Mary Hospital, Seoul 137-701, Korea, Republic of; Active, not recruiting

Yonsei University, Severance Hospital, Seoul 120-752, Korea, Republic of; Active, not recruiting

Wojewodzki Szpital Specjalistyczny im Dluskeigo, Bialystok 15-540, Poland; Active, not recruiting

Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza, Bydgoszcz 85-030, Poland; Withdrawn

Szpital Specjalistyczny, Chorzow 41-500, Poland; Active, not recruiting

Oddziak Obserwacyjno-Zakazny, Lodz 91-347, Poland; Active, not recruiting

Klinika Chorob Zakaznych AM, Wroclaw 50-349, Poland; Active, not recruiting

Constanta Clinical Hosp. for Infectious Diseases (attn: Halikidis Stela, MD), Constanta 900708, Romania; Active, not recruiting

Gastromond SRL, Constanta 900635, Romania; Withdrawn

Institutul de Gastroenterologie si Hepatologie lasi, Iasi 700506, Romania; Active, not recruiting

Spitalul Clinic Judetean de Urgenta Timisoara, Timisoara 300736, Romania; Withdrawn

Limited Liability Company "Modern Medicine Clinic", Moscow 121293, Russian Federation; Active, not recruiting

Research Institute of Nutrition (RAMS), Department of Gastroenterology and Hepatology, Moscow 109240, Russian Federation; Withdrawn

State fiscal health agency of Moscow "Infectious Clinical Hospital 1 Moscow Health Department", Moscow 125367, Russian Federation; Active, not recruiting

University Clinical Hospital #1, Moscow 119991, Russian Federation; Active, not recruiting

Institute of Clinical Immunology RAMS, Clinic of Immunopathology, Novosibirsk 630099, Russian Federation; Active, not recruiting

Novosobirsk State Medical University, Novosibirsk 630091, Russian Federation; Active, not recruiting

State Budgetary Healthcare Institution "State Novosibirsk Regional Clinical Hospital", Novosibirsk 630087, Russian Federation; Active, not recruiting

Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov, Saint-Petersburg 194044, Russian Federation; Active, not recruiting

Municipal Clinical Hospital n.a. S.P. Botkin, Saint-Petersburg 191167, Russian Federation; Active, not recruiting

Research Institute of Influenza, Saint-Petersburg 197376, Russian Federation; Active, not recruiting

Changi General Hospital Pte Ltd., Singapore 529889, Singapore; Withdrawn

National University Hospital Singapore, Singapore 119074, Singapore; Withdrawn

Hospital Universitari Vall d'Hebron, Barcelona 8035, Spain; Active, not recruiting

Hospital Universitario Puerta de Hierro, Majadahonda 28020, Spain; Withdrawn

Hospital Universitario Virgen del Rocio, Sevilla 4103, Spain; Withdrawn

Hualien Tzu Chi Medical Center, Hualien 970, Taiwan; Active, not recruiting

Kaohsiung Med. College Hosp. Dept. of Internal Medicine, Kaohsiung 80756, Taiwan; Active, not recruiting

Taichung Veterans General Hospital, Taichung 40705, Taiwan; Active, not recruiting

National Cheng Kung University Hospital, Tainan 70428, Taiwan; Active, not recruiting

National Taiwan University Hospital, Taipei 10002, Taiwan; Active, not recruiting

Ankara University Medical Faculty Hospital, Ankara 6590, Turkey; Active, not recruiting

University of Uludag, Gorukle-Bursa 16059, Turkey; Active, not recruiting

Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi, Istanbul 34098, Turkey; Active, not recruiting

Ege Universitesi Tip Fakultesi Hastanesi, Izmir 35040, Turkey; Active, not recruiting

Barts & The London NHS Trust, London E1 1BB, United Kingdom; Active, not recruiting

King's College Hospital, London SE5 9RS, United Kingdom; Active, not recruiting

Royal Free Hospital, London NW3 2QG, United Kingdom; Withdrawn

Nottingham University Hospitals NHS Trust, Nottingham NG7 2UH, United Kingdom; Active, not recruiting

Heritage Medical Research Clinic, Calgary, Alberta T2N 4Z6, Canada; Active, not recruiting

University of Alberta, Edmonton, Alberta T6G 2X8, Canada; Active, not recruiting

Hopital Civil de Strasbourg, Strasbourg, Alsace 67091, France; Active, not recruiting

Hyderabad, Andhra Pradesh 500082, India; Active, not recruiting

Global Hospitals, Hyderabad, Andhra Pradesh 500004, India; Active, not recruiting

Auckland Clinical Studies Limited, Grafton, Auckland 1142, New Zealand; Active, not recruiting

Dr. John Farley Inc., Vancouver, British Columbia V6A 4B6, Canada; Active, not recruiting

Gastrointestinal Research Institute (GIRI), Vancouver, British Columbia V6Z 2K5, Canada; Active, not recruiting

Liver and Intestinal Research Centre, Vancouver, British Columbia V5Z 1H2, Canada; Active, not recruiting

University of British Columbia, Vancouver, British Columbia V5Z 1M9, Canada; Active, not recruiting

Vancouver Infectious Disease Research and Care Centre, Vancouver, British Columbia V6Z 2C7, Canada; Active, not recruiting

Institutul National de Boli Infectioase Prof.Dr. Matei Bals, Bucharest, Bucuresti 21105, Romania; Active, not recruiting

Asian Pacific Liver Center, Los Angeles, California 90057, United States; Active, not recruiting

Stanford University Medical Center, Palo Alto, California 94304, United States; Active, not recruiting

Huntington Medical Research Institutes, Pasadena, California 91105, United States; Active, not recruiting

Research and Education, Inc., San Diego, California 92105, United States; Active, not recruiting

University California San Francisco (UCSF), San Francisco, California 94110, United States; Active, not recruiting

Silicon Valley Research Institute, San Jose, California 95128, United States; Active, not recruiting

SoonChunHyang University Hospital Cheonan, Cheonan, Chungcheongnam-Do 330-721, Korea, Republic of; Withdrawn

Sir Ganga Ram Hospital, Rajinder Nagar, Delhi 110060, India; Withdrawn

Dicle University Medical Faculty Department of Infectious Diseases, Diyarbakir, Diyarbakri 21280, Turkey; Active, not recruiting

University of Miami, Miami, Florida 33136, United States; Active, not recruiting

Guangzhou No.8 People's Hospital, Guangzhou, Guangdong 510060, China; Not yet recruiting

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, China; Not yet recruiting

The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510630, China; Not yet recruiting

The 1st Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, China; Not yet recruiting

The Affiliated Hospital of Guiyang Medical College, Guiyang, Guizhou 500000, China; Not yet recruiting

Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, Korea, Republic of; Active, not recruiting

The People's Hospital of Hainan Province, Haikou, Hainan 570311, China; Not yet recruiting

Medanta-The Medicity, Gurgaon, Haryana 122001, India; Withdrawn

The 3rd Hospital of Hebei Medical University, Shijiazhuang, Hebei 050051, China; Not yet recruiting

Princess Margaret Hospital, Kowloon, Hong Kong, China; Active, not recruiting

Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology, Wuhan, Hubei 430030, China; Not yet recruiting

The 2nd Xiangya Hospital Central South University, Changsha, Hunan 410011, China; Not yet recruiting

XiangYa Hospital Central South University, Changsha, Hunan 410008, China; Not yet recruiting

Jiangsu Provincial People' Hospital, Nanjing, Jiangsu 210029, China; Not yet recruiting

Nanjing No. 2 Hospital, Nanjing, Jiangsu 210003, China; Not yet recruiting

The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330000, China; Recruiting

The First Hospital of Jilin University, Changchun, Jilin 130021, China; Not yet recruiting

MS Ramaiah Medical College and Hospital, Bangalore, Karnataka 560054, India; Withdrawn

Shengjing Hospital of China Medical University, Shenyang, Liaoning 110022, China; Not yet recruiting

The sixth People's Hospital of Shenyang, Shenyang, Liaoning 110006, China; Not yet recruiting

Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals, Parel, Maharashtra 400012, India; Active, not recruiting

Seth GS Medical College and KEM Hospital, Mumbai, Maharastra 400012, India; Active, not recruiting

University of Manitoba, Health Science Center, Winnipeg, Manitoba R3E 3P4, Canada; Active, not recruiting

Baltimore, Maryland 21201, United States; Withdrawn

Digestive Disease Associates, PA, Baltimore, Maryland 21229, United States; Active, not recruiting

Orlando Clinical, Detroit, Michigan 48202, United States; Active, not recruiting

ID Care, Hillsborough, New Jersey 08844, United States; Active, not recruiting

Medical Procare, PLLC, Flushing, New York 11355, United States; Active, not recruiting

Sing Chan Private Practice, Flushing, New York 11355, United States; Active, not recruiting

Karaganda State Medical Institute, Koltsovo, Novosibirsk 630559, Russian Federation; Active, not recruiting

Ottawa, Ontario K1H 8L6, Canada; Withdrawn

Toronto Liver Centre, Toronto, Ontario M6H 3M1, Canada; Active, not recruiting

Toronto Western Hospital, Toronto, Ontario M5T 2S8, Canada; Active, not recruiting

University Health Network / Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada; Active, not recruiting

Xiaoli Ma, PC, Philadelphia, Pennsylvania 19107, United States; Active, not recruiting

Dayanand Medical College & Hospital, Ludhiana, Punjab 141001, India; Withdrawn

Hôpital de la Croix Rousse, Lyon, Rhône-Alpes 69317, France; Active, not recruiting

Jinan Infectious Disease Hospital, Jinan, Shandong 250021, China; Not yet recruiting

First Affiliated Hospital of Xi'an Jiaotong, Xi'an, Shanxi 710061, China; Not yet recruiting

West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; Not yet recruiting

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Withdrawn

The North Texas Research Institute, Arlington, Texas 76012, United States; Withdrawn

Houston, Texas 77005, United States; Withdrawn

Monash Medical Centre, Clayton, Victoria 3168, Australia; Active, not recruiting

Western Hospital- Footscray Hospital, Footscray, Victoria 3011, Australia; Active, not recruiting

Austin Health, Heidelberg, Victoria 3084, Australia; Active, not recruiting

Royal Melbourne Hospital, Parkville, Victoria 3050, Australia; Active, not recruiting

Hunter Holmes McGuire VA DVMC, Richmond, Virginia 23249, United States; Active, not recruiting

Institute of Post Graduate Medical Education And Research, Kolkata, West Bengal 700020, India; Active, not recruiting

Royal Perth Hospital, Perth, Western Australia 6000, Australia; Active, not recruiting

No.1 Hospital Affiliated to Kunming Medical College, Kunming, Yunnan 650032, China; Not yet recruiting

Hopital Henri Mondor, Créteil Cedex, Île-de-France 94010, France; Withdrawn

Additional Information

Starting date: September 2013
Last updated: July 31, 2015

Page last updated: August 23, 2015

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