LAST UPDATED
October 10, 2023
Clinicaltrials.gov ID
EudraCT ID
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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HBeAg-positive Chronic Hepatitis B
Gender
N/A
Date
September 2013 - November 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.
- 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
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
Tufts Medical Center, Inc
Boston, Massachusetts, United States, 02111
Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
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
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
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
University Health Network / Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
BYL Nair Hospital & T N Medical College
Mumbai, Maharashtra, India, 400008
Government Medical College and Superspecialty Hospital
Nagpur, Maharashtra, India, 440003
Postgraduate Institute of Medical Education & Research
Chandigarh, India, 160012
YR Gaitonde Centre for AIDS Research and Education
Chennai, India, 600113
Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
Hyderabad, India, 500058
Postgraduate Institute of Medical Education & Research
Kolkata, India, 700020
Global Hospital Super Specialty & Transplant Centre
Pārel, India, 400 012
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Azienda Ospedaliero Universitaria Ospedali Riuniti di
Foggia, Italy, 71100
Policlinico Universitario G. Martino via Consolare
Messina, Italy, 98124
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
National Hospital Organization Nagasaki Medical Center
Ōmura, Japan, 856-8562
Medical Hospital of Tokyo Medical and Dental University
Tokyo, Japan, 113-8519
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
Bialystok, Poland, 15-540
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, Romania, 021105
Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
Bucharest, Romania, 030303
Spitatul Clinic de Boli Infectioase Constanta
Constanța, Romania, 900709
Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, Romania, 300736
Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Lipetsk, Russia, 398043
1st Moscow State Medical University University Clinical Hospital #3
Moscow, Russia, 119435
Limited Liability Company "Modern Medicine Clinic"
Moscow, Russia, 121170
Institute of Clinical Immunology RAMS, Clinic of Immunopathology
Novosibirsk, Russia, 630084
Scientific Research Institute of Clinical Immunology
Novosibirsk, Russia, 630099
Municipal Clinical Hospital n.a. S.P. Botkin
Saint Petersburg, Russia, 191167
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Russia, 620102
Kosin University College of Medicine
Busan, Seo-gu, South Korea, 602702
SoonChunHyang University Hospital Cheonan
Cheonan, South Korea, 330-721
Keimyung University Dongsan Medical Center
Daegu, South Korea, 700-712
Inje University Ilsan Paik Hospital
Gyeonggi-do, South Korea, 411-706
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea, 463-707
Severance Hospital Yonsei University Health System
Seoul, South Korea, 120-752
Pusan National University Yangsan Hospital
Yangsan, South Korea, 626-770
Kaohsiung Med. College Hosp. Dept. of Internal Medicine
Kaohsiung City, Taiwan, 80756
Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
Ankara, Turkey (Türkiye), 06100
Dicle University Medical Faculty Department of Infectious Diseases
Diyarbakır, Turkey (Türkiye), 21280
Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon
Istanbul, Turkey (Türkiye), 34098
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 35100
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
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