LAST UPDATED
June 18, 2026
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescent Subjects With Chronic Hepatitis B Virus Infection
PROTOCOL SUMMARY
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.
View moreParticipation requirements
Age
2 years - 17 years
Sex
All
Healthy Volunteers
No
Age
2 years - 17 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Chronic Hepatitis B
Gender
N/A
Date
November 2016 - September 2026
Study Type
Interventional
Study Phase
Phase 2
Product
TAF, Placebo
Eligibility information
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/legal guardian)
- 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 central laboratory range)
- Treatment-naive or treatment-experienced will be eligible for enrollment.
- Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m^2 (using the Schwartz formula)
- Normal ECG
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/mL an 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-1 antitrypsin deficiency, cholangitis)
- Received solid organ or bone marrow transplant
- Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants
- Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
- Malignancy within the 5 years prior to screening. Individuals under evaluation for possible malignancy are not eligible.
- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (39)
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94158
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
The Children's Hospital at Montefiore
The Bronx, New York, United States, 10467
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Texas Children's Hospital - Main Hospital
Houston, Texas, United States, 77030
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Institute of Post Graduation Medical Education & Research
Kolkata, India, 700020
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
Bucharest, Romania, 11743
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"
Bucharest, Romania, 21105
Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, Russia, 115446
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases
Saint Petersburg, Russia, 197022
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
Tatarstan, Russia, 420110
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 33305
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