LAST UPDATED
September 25, 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-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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
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
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
Hunter Holmes McGuire VA DVMC
Richmond, Virginia, United States, 23249
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
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
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, Canada, V6Z 2C7
Gastrointestinal Research Institute (GIRI)
Vancouver, British Columbia, Canada, V6Z 2K5
Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals
Hyderabad, Andhra Pradesh, India, 500058
Seth GS Medical College and KEM Hospital
Mumbai, Maharashtra, India, 400012
Global Hospital Super Specialty & Transplant Centre
Pārel, Mumbai, India, 400 012
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
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
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
Kyushu University Hospital Fukuoka
Fukuoka, Fukuoka-shi, Japan, 812-8582
National Hospital Organization Nagasaki Medical Center
Omura-shi, Nagasaki, Japan, 856-8562
The Hospital of Hyogo College of Medicine
Nishinomiya, Japan, 663-8501
Medical Hospital of Tokyo Medical and Dental University
Tokyo, Japan, 113-8519
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika
Bialystok, Poland, 15-540
Centrum Badan Klinicznych - Przychodnia Badan
Wroclaw, Poland, 50-349
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, Bucharest, Romania, 021105
Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"
Bucharest, Romania, 030303
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
Bucharest, Romania, 21105
Spitatul Clinic de Boli Infectioase Constanta
Constanța, Romania, 900708
Infection Center LLC Building 20, MSH #163 Territory Koltsovo
Kol'tsovo, Novosibirsk Oblast, Russia, 630559
1st Moscow State Medical University University Clinical Hospital #3
Moscow, Russia, 119991
Limited Liability Company "Modern Medicine Clinic"
Moscow, Russia, 121293
Infectious Clinical Hospital #1 of Moscow Healthcare Department
Moscow, Russia, 125367
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russia, 630087
Scientific Research Institute of Clinical Immunology
Novosibirsk, Russia, 630091
Clinical Infectious Hospital named after S.P.Botkin
Saint Petersburg, Russia, 191167
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Dicle University Medical Faculty Department of Infectious Diseases
Diyarbakır, Diyarbakri, Turkey (Türkiye), 21280
Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci
Ankara, Turkey (Türkiye), 06590
Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji
Bursa, Turkey (Türkiye), 16059
Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye), 34098
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 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
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