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-Negative, 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)-negative chronic hepatitis B virus (HBV) infection.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

HBeAg-negative Chronic Hepatitis B

Gender

N/A

Date

September 2013 - September 2015

Study Type

Interventional

Study Phase

Phase 3

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.
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).

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 (105)

Asian Pacific Liver Center

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

University California San Francisco (UCSF)

San Francisco, California, United States, 94110

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

Henry Ford Health System

Detroit, Michigan, United States, 48202

ID Care

Hillsborough, New Jersey, United States, 08844

Sing Chan Private Practice

Flushing, New York, United States, 11354

New Discovery, LLC

Flushing, New York, United States, 11355

Xiaoli Ma, PC

Philadelphia, Pennsylvania, United States, 19107

Hunter Holmes McGuire VA DVMC

Richmond, Virginia, United States, 23249

Monash Medical Centre

Clayton, Victoria, Australia, 3168

St. Vincent's Hospital

Fitzroy, Victoria, Australia, 3065

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Zeidler Ledcor Centre Division of Gastroenterology

Edmonton, Alberta, Canada, T6G 2X8

Liver and Intestinal Research Centre

Vancouver, British Columbia, Canada, V5Z 1H3

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

Winnipeg, Manitoba, Canada, R3E 3P4

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Inspiration Research Limited

Toronto, Ontario, Canada, M5T 2S8

Toronto Liver Centre

Toronto, Ontario, Canada, M6H 3M1

Hôpital de la Croix Rousse

Lyon cedex 04, France, 69317

Hopital Civil de Strasbourg- CHU Service

Strasbourg, France, 67000

Queen Mary Hospital

Hong Kong, Hong Kong SAR, Hong Kong

Princess Margaret Hospital

Kwai Chung, Hong Kong

Prince of Wales Hospital

Shatin, Hong Kong

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Global Hospitals

Hyderabad, Andhra Pradesh, India, 500004

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

Hyderabad, Andhra Pradesh, India, 500058

All India Institute of Medical Sciences

New Delhi, Delhi, India, 110029

Nirmal Hospital

Surat, Gujarat, India, 395002

Seth GS Medical College and KEM Hospital

Mumbai, Maharastra, India, 400012

Global Hospital Super Specialty & Transplant Centre

Parel, Mumbai, India, 400 012

S. R Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India, 302001

Institute of Post Graduate Medical Education And Research

Kolkata, West Bengal, India, 700020

Postgraduate Institute of Medical Education and Research

Chandigarh, India, 160012

Institute of Liver and Biliary Sciences

New Delhi, India, 110070

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy, 71013

Azienda Ospedaliera S. Orsola - Malpighi

Bologna, Italy, 40138

Azienda Ospedaliero Universitaria Ospedali

Foggia, Italy, 71122

Azienda Ospedaliero- Universitaria Pisana

Pisa, Italy, 56124

Kurume University Hospital

Kurume-shi, Fukuoka-ken, Japan, 830-0011

Kyushu University Hospital Fukuoka

Fukuoka, Fukuoka-shi, Japan, 812-8582

National Hospital Organization Nagasaki Medical Center

Omura-shi, Nagasaki, Japan, 856-8562

Osaka University Hospital

Suita, Osaka, Japan, 565-0871

Shin-Kokura Hospital

Kitakyushu, Japan, 803-8505

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Japan Red Cross Musashino Hospital

Musashino, Japan, 180-8610

The Hospital of Hyogo College of Medicine

Nishinomiya, Japan, 663-8501

Osaka Red Cross Hospital

Osaka, Japan, 543-8555

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Medical Hospital of Tokyo Medical and Dental University

Tokyo, Japan, 113-8519

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

Keimyung University Dongsan Medical Center

Daegu, Korea, Republic of, 42601

Yonsei University, Severance Hospital

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Gangnam Severance Hospital

Seoul, Korea, Republic of, 06273

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Seoul Saint Mary Hospital

Seoul, Korea, Republic of, 06591

Chung-Ang University Hospital

Seoul, Korea, Republic of, 06973

Korea University Guro Hospital

Seoul, Korea, Republic of, 08308

Auckland Clinical Studies Limited

Auckland, New Zealand, 1010

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

Bialystok, Poland, 15-540

Szpital Specjalistyczny w Chorzowie Oddział

Chorzow, Poland, 41-500

SPZOZ, Wojewódzki Specjalistyczny Szpital

Lodz, Poland, 91-347

Centrum Badan Klinicznych - Przychodnia Badan

Wroclaw, Poland, 50-349

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

Bucharest, Bucuresti, Romania, 021105

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

Bucuresti, Romania, 030303

Institutul National de Boli Infectioase Prof.Dr. Matei Bals

Bucuresti, Romania, 21105

Spitatul Clinic de Boli Infectioase Constanta

Constanta, Romania, 900708

Gastromedica SRL

Iasi, Romania, 700506

Infection Center LLC Building 20, MSH #163 Territory Koltsovo

Koltsovo, Novosibirsk, Russian Federation, 630559

1st Moscow State Medical University University Clinical Hospital #3

Moscow, Russian Federation, 119991

Limited Liability Company "Modern Medicine Clinic"

Moscow, Russian Federation, 121293

Infectious Clinical Hospital #1 of Moscow Healthcare Department

Moscow, Russian Federation, 125367

Novosibirsk State Medical University

Novosibirsk, Russian Federation, 630084

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russian Federation, 630087

Scientific Research Institute of Clinical Immunology

Novosibirsk, Russian Federation, 630091

Clinical Infectious Hospital named after S.P.Botkin

Saint-Petersburg, Russian Federation, 191167

Kirov Medical Military Academy

Saint-Petersburg, Russian Federation, 194044

Research Institute of Influenza

Saint-Petersburg, Russian Federation, 197376

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hualien Tzu Chi Hospital

Hualien City, Taiwan, 970

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 807

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Cheng Kung University Hospital

Tainan, Taiwan, 704

National Taiwan University Hospital

Taipei, Taiwan, 10002

Dicle University Medical Faculty Department of Infectious Diseases

Diyarbakir, Diyarbakri, Turkey, 21280

Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

Ankara, Turkey, 06590

Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji

Bursa, Turkey, 16059

Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi

Istanbul, Turkey, 34098

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey, 35040

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

Barts and The London NHS Trust Royal London Hospital

London, United Kingdom, E1 1BB

King's College Hospital

London, United Kingdom, SE5 9RS

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