Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
TAF
Placebo
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion criteria:
Males and non-pregnant, non-lactating females
Weight at screening as follows:
Cohort 1 = ≥ 35 kg (≥ 77 lbs)
Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs)
Cohort 2 Group 2 = ≥ 14 kg to < 25 kg (≥ 30 lbs to <55 lbs)
Cohort 2 Group 3 = ≥ 10 kg to < 14 kg (≥ 22 lbs to < 30 lbs) or
14 kg to < 25 kg (≥ 30 lbs to < 55 lbs)
Willing and able to provide written informed consent/assent (child and parent/legalguardian)
Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:
Screening HBV DNA ≥ 2 × 10^4 IU/mL
Screening serum ALT > 45 U/L (> 1.5 × ULN: 30 U/L) and ≤ 10 × ULN (by centrallaboratory range)
Treatment-naive or treatment-experienced will be eligible for enrollment.
Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m^2 (using the Schwartzformula)
Normal ECG
Exclusion
Key Exclusion criteria:
Females who are pregnant or breastfeeding
Males and females of reproductive potential who are unwilling to use an "effective",protocol-specified method(s) of contraception during the study.
Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mLan imaging study is required)
Any history of, or current evidence of, clinical hepatic decompensation
Abnormal hematological and biochemical parameters
Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1antitrypsin deficiency, cholangitis)
Received solid organ or bone marrow transplant
Currently receiving therapy with immunomodulators (eg, corticosteroids), orimmunosuppressants
Significant renal, cardiovascular, pulmonary, or neurological disease in the opinionof the Investigator
Malignancy within the 5 years prior to screening. Individuals under evaluation forpossible malignancy are not eligible.
Current alcohol or substance abuse judged by the investigator to potentiallyinterfere with subject compliance.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Cliniques Universitaires Saint-LUC UCL
Brussels, 1200
BelgiumCompleted
The Hospital for Sick Children
Toronto, M5G 1X8
CanadaSite Not Available
BC Children's Hospital
Vancouver, V6H3V4
CanadaSite Not Available
Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hospital
Shatin,
Hong KongCompleted
GCS Medical Hospital & Research Center
Ahmedabad, 380025
IndiaActive - Recruiting
SR Kalla Memorial Gastro And General Hospital
Jaipur, 302001
IndiaSite Not Available
Pratha Gastro Liver Center
Kanpur, 208012
IndiaSite Not Available
Institute of Post Graduation Medical Education & Research
Kolkata, 700020
IndiaActive - Recruiting
M. V Hospital and Research Center
Lucknow, 226003
IndiaActive - Recruiting
LTMMC & LTMG Hospital
Mumbai, 400022
IndiaActive - Recruiting
Seth GS Medical College and KEM Hospital
Mumbai, 400012
IndiaActive - Recruiting
Seth GS Medical College and KEM hospital, Parel
Mumbai, 400022
IndiaActive - Recruiting
Khalatkar Hospital
Nagpur, 440009
IndiaActive - Recruiting
Midas Multispecility Hospital PVT. LTD.
Nagpur, 440010
IndiaSite Not Available
Nandita Hospital and Research Centre
Nagpur, 440003
IndiaSite Not Available
All India Institute of Medical Sciences
New Delhi, 110029
IndiaActive - Recruiting
SIDS Hospital and Research Centre
Surat, 395002
IndiaActive - Recruiting
Surat Institute of Digestive Sciences
Surat, 395002
IndiaActive - Recruiting
Samvedna Hospital
Varanasi, 221005
IndiaActive - Recruiting
AOU di Bologna - Policlinico S. Orsola Malpighi - Dipartimento Malattic dell'Apparato Digerente e Medicina Intema
Bologna, 40138
ItalySite Not Available
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 5505
Korea, Republic ofCompleted
Samsung Medical Center
Seoul, 6351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofSite Not Available
Auckland Clinical Studies Limited
Grafton, Auckland 1010
New ZealandSite Not Available
Auckland Clinical Studies Limited
Auckland, 1010
New ZealandActive - Recruiting
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"
Bucharest, 21105
RomaniaSite Not Available
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
Bucharest, 11743
RomaniaSite Not Available
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
Kazan, Tatarstan 420110
Russian FederationSite Not Available
Krasnoyarsk Regional Clinical Center of Maternal and Child Welfare
Krasnoyarsk, 660074
Russian FederationSite Not Available
Federal Budgetary Institution of Science "Central Scientific-Research Institute of Epidemiology"
Moscow, 111123
Russian FederationSite Not Available
Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, 115446
Russian FederationSite Not Available
Scientific Center of Children's Health of the Ministry of Health of the Russian Federation
Moscow, 119991
Russian FederationSite Not Available
Federal Budgetary Scientific Institution Pasteur St. Petersburg Scientific Research Institute of Epidemiology and Microbiology
Saint Petersburg, 197101
Russian FederationSite Not Available
Federal Budgetary Scientific Institution Pasteur St. Petersburg Scientific Research Institute of Epidemiology and Microbiology
Saint-Petersburg, 197101
Russian FederationSite Not Available
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases
Saint-Petersburg, 197022
Russian FederationSite Not Available
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
Tatarstan, 420110
Russian FederationSite Not Available
Limited Medical Company Hepatolog
Tolyatti, 445009
Russian FederationSite Not Available
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 83301
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan, 704
TaiwanCompleted
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Taipei Mackay Memorial Hospital
Taipei, 104
TaiwanSite Not Available
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305
TaiwanActive - Recruiting
Children's Hospital of Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
Rady Childrens Hospital
San Diego, California 92123
United StatesActive - Recruiting
University of California, San Francisco (UCSF)
San Francisco, California 94158
United StatesActive - Recruiting
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Miami/Schiff Center for Liver Diseases
Miami, Florida 33136
United StatesSite Not Available
AdventHealth Medical Group
Orlando, Florida 32803
United StatesSite Not Available
Children's Healthcare of Atlanta
Atlanta, Georgia 30322
United StatesSite Not Available
Indiana University School of Medicine
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesActive - Recruiting
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota 55455
United StatesSite Not Available
Children's Mercy Hospital
Kansas City, Missouri 64108
United StatesActive - Recruiting
Children's Hospital & Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
The Children's Hospital at Montefiore
Bronx, New York 10467
United StatesCompleted
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesActive - Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United StatesCompleted
Children's Medical Center
Dallas, Texas 75235
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesCompleted
Texas Children's Hospital - Main Hospital
Houston, Texas 77030
United StatesActive - Recruiting
American Research Corporation at Texas Liver Institute
San Antonio, Texas 78215
United StatesCompleted
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
West Virginia University Hospitals
Morgantown, West Virginia 26506
United StatesSite Not Available
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