Actively Recruiting
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
Led by Gilead Sciences · Updated on 2026-04-03
150
Participants Needed
62
Research Sites
673 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.
CONDITIONS
Official Title
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and non-pregnant, non-lactating females
- Weight at screening as follows: Cohort 1 �35 kg (77 lbs) or more; Cohort 2 Group 1 �25 kg (55 lbs) or more; Cohort 2 Group 2 between 14 kg and less than 25 kg (30 lbs to less than 55 lbs); Cohort 2 Group 3 between 10 kg and less than 14 kg (22 lbs to less than 30 lbs) or 14 kg to less than 25 kg (30 lbs to less than 55 lbs)
- Willing and able to provide written informed consent/assent (child and parent/legal guardian)
- Documented chronic hepatitis B infection (e.g., HBsAg-positive for 6 months or more)
- HBeAg-positive or HBeAg-negative chronic HBV infection with all of the following: screening HBV DNA at least 2 x 10^4 IU/mL; screening serum ALT above 45 U/L and less than or equal to 10 times the upper limit of normal
- Treatment-naive or treatment-experienced
- Estimated creatinine clearance of 80 mL/min/1.73m2 or higher (Schwartz formula)
- Normal ECG
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Males and females unwilling to use effective contraception during the study
- Coinfection with hepatitis C virus, HIV, or hepatitis D virus
- Evidence of hepatocellular carcinoma (if alpha-fetoprotein is above 50 ng/mL, imaging study is required)
- History or current evidence of clinical hepatic decompensation
- Abnormal blood or biochemical test results
- Chronic liver disease not caused by hepatitis B (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
- Received solid organ or bone marrow transplant
- Currently receiving immunomodulator or immunosuppressant therapy
- Significant kidney, heart, lung, or nervous system disease as judged by the investigator
- Cancer within the past 5 years or under evaluation for cancer
- Current alcohol or substance abuse that may affect study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 62 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Rady Childrens Hospital
San Diego, California, United States, 92123
Actively Recruiting
3
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94158
Active, Not Recruiting
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Active, Not Recruiting
5
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
Withdrawn
6
AdventHealth Medical Group
Orlando, Florida, United States, 32803
Withdrawn
7
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Withdrawn
8
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55455
Withdrawn
11
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
12
Children's Hospital & Medical Center
Omaha, Nebraska, United States, 68198
Withdrawn
13
The Children's Hospital at Montefiore
The Bronx, New York, United States, 10467
Completed
14
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Active, Not Recruiting
15
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Completed
16
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Completed
17
Children's Medical Center
Dallas, Texas, United States, 75235
Withdrawn
18
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Completed
19
Texas Children's Hospital - Main Hospital
Houston, Texas, United States, 77030
Actively Recruiting
20
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215
Completed
21
Seattle Children's Hospital
Seatlle, Washington, United States, 98105
Actively Recruiting
22
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
Withdrawn
23
Cliniques Universitaires Saint-LUC UCL
Brussels, Belgium, 1200
Completed
24
The Hospital for Sick Children
Toronto, Canada, M5G 1X8
Withdrawn
25
BC Children's Hospital
Vancouver, Canada, V6H3V4
Withdrawn
26
Prince of Wales Hospital
Shatin, Hong Kong
Completed
27
GCS Medical Hospital & Research Center
Ahmedabad, India, 380025
Withdrawn
28
SR Kalla Memorial Gastro And General Hospital
Jaipur, India, 302001
Withdrawn
29
Pratha Gastro Liver Center
Kanpur, India, 208012
Withdrawn
30
Institute of Post Graduation Medical Education & Research
Kolkata, India, 700020
Actively Recruiting
31
M. V Hospital and Research Center
Lucknow, India, 226003
Actively Recruiting
32
Seth GS Medical College and KEM Hospital
Mumbai, India, 400012
Actively Recruiting
33
LTMMC & LTMG Hospital
Mumbai, India, 400022
Active, Not Recruiting
34
Nandita Hospital and Research Centre
Nagpur, India, 440003
Withdrawn
35
Khalatkar Hospital
Nagpur, India, 440009
Actively Recruiting
36
Midas Multispecility Hospital PVT. LTD.
Nagpur, India, 440010
Withdrawn
37
All India Institute of Medical Sciences
New Delhi, India, 110029
Actively Recruiting
38
SIDS Hospital and Research Centre
Surat, India, 395002
Actively Recruiting
39
Samvedna Hospital
Varanasi, India, 221005
Actively Recruiting
40
AOU di Bologna - Policlinico S. Orsola Malpighi - Dipartimento Malattic dell'Apparato Digerente e Medicina Intema
Bologna, Italy, 40138
Withdrawn
41
Auckland Clinical Studies Limited
Auckland, New Zealand, 1010
Withdrawn
42
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
Bucharest, Romania, 11743
Active, Not Recruiting
43
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"
Bucharest, Romania, 21105
Active, Not Recruiting
44
Krasnoyarsk Regional Clinical Center of Maternal and Child Welfare
Krasnoyarsk, Russia, 660074
Withdrawn
45
Federal Budgetary Institution of Science "Central Scientific-Research Institute of Epidemiology"
Moscow, Russia, 111123
Withdrawn
46
Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, Russia, 115446
Completed
47
Scientific Center of Children's Health of the Ministry of Health of the Russian Federation
Moscow, Russia, 119991
Withdrawn
48
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases
Saint Petersburg, Russia, 197022
Completed
49
Federal Budgetary Scientific Institution Pasteur St. Petersburg Scientific Research Institute of Epidemiology and Microbiology
Saint Petersburg, Russia, 197101
Withdrawn
50
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
Tatarstan, Russia, 420110
Completed
51
Limited Medical Company Hepatolog
Tolyatti, Russia, 445009
Completed
52
Kyungpook National University Hospital
Daegu, South Korea, 41944
Completed
53
Seoul National University Hospital
Seoul, South Korea, 03080
Withdrawn
54
Asan Medical Center
Seoul, South Korea, 5505
Completed
55
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
56
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Withdrawn
57
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
58
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Active, Not Recruiting
59
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Completed
60
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
61
Taipei Mackay Memorial Hospital
Taipei, Taiwan, 104
Withdrawn
62
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
G
Gilead Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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