Study Details

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.

Participation Requirements

Age

2 Years - 17 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Chronic Hepatitis B

Gender

N/A

Date

November 2016 - September 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE2

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 (62)

Children's Hospital of Los Angeles

Los Angeles, California, United States, 90027

Rady Childrens Hospital

San Diego, California, United States, 92123

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94158

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

University of Miami/Schiff Center for Liver Diseases

Miami, Florida, United States, 33136

AdventHealth Medical Group

Orlando, Florida, United States, 32803

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Johns Hopkins University

Baltimore, Maryland, United States, 21287

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States, 55455

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Children's Hospital & Medical Center

Omaha, Nebraska, United States, 68198

The Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Children's Medical Center

Dallas, Texas, United States, 75235

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

West Virginia University Hospitals

Morgantown, West Virginia, United States, 26506

Cliniques Universitaires Saint-LUC UCL

Brussels, Belgium, 1200

The Hospital for Sick Children

Toronto, Canada, M5G 1X8

BC Children's Hospital

Vancouver, Canada, V6H3V4

Prince of Wales Hospital

Shatin, Hong Kong

GCS Medical Hospital & Research Center

Ahmedabad, India, 380025

SR Kalla Memorial Gastro And General Hospital

Jaipur, India, 302001

Pratha Gastro Liver Center

Kanpur, India, 208012

Institute of Post Graduation Medical Education & Research

Kolkata, India, 700020

M. V Hospital and Research Center

Lucknow, India, 226003

Seth GS Medical College and KEM Hospital

Mumbai, India, 400012

LTMMC & LTMG Hospital

Mumbai, India, 400022

Nandita Hospital and Research Centre

Nagpur, India, 440003

Khalatkar Hospital

Nagpur, India, 440009

Midas Multispecility Hospital PVT. LTD.

Nagpur, India, 440010

All India Institute of Medical Sciences

New Delhi, India, 110029

SIDS Hospital and Research Centre

Surat, India, 395002

Samvedna Hospital

Varanasi, India, 221005

AOU di Bologna - Policlinico S. Orsola Malpighi - Dipartimento Malattic dell'Apparato Digerente e Medicina Intema

Bologna, Italy, 40138

Auckland Clinical Studies Limited

Auckland, New Zealand, 1010

Spitalul Grigore Alexandrescu-Sectia Pediatrie III

Bucharest, Romania, 11743

Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"

Bucharest, Romania, 21105

Krasnoyarsk Regional Clinical Center of Maternal and Child Welfare

Krasnoyarsk, Russia, 660074

Federal Budgetary Institution of Science "Central Scientific-Research Institute of Epidemiology"

Moscow, Russia, 111123

Federal Research Centre of Nutrition, Biotechnology and Food Safety

Moscow, Russia, 115446

Scientific Center of Children's Health of the Ministry of Health of the Russian Federation

Moscow, Russia, 119991

Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases

Saint Petersburg, Russia, 197022

Federal Budgetary Scientific Institution Pasteur St. Petersburg Scientific Research Institute of Epidemiology and Microbiology

Saint Petersburg, Russia, 197101

Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov

Tatarstan, Russia, 420110

Limited Medical Company Hepatolog

Tolyatti, Russia, 445009

Kyungpook National University Hospital

Daegu, South Korea, 41944

Seoul National University Hospital

Seoul, South Korea, 03080

Asan Medical Center

Seoul, South Korea, 5505

Samsung Medical Center

Seoul, South Korea, 6351

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807

Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, 83301

National Cheng Kung University Hospital

Tainan, Taiwan, 704

National Taiwan University Hospital

Taipei, Taiwan, 100

Taipei Mackay Memorial Hospital

Taipei, Taiwan, 104

Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan, 33305

Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

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