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RECRUITING

NCT02932150

PHASE2

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2016-11

Completion Date

2029-10

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Chronic Hepatitis B

Interventions

DRUG

TAF

Administered orally once daily

DRUG

Placebo

Administered orally once daily

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/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 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/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 (62)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Rady Childrens Hospital

San Diego, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University of Miami/Schiff Center for Liver Diseases

Miami, Florida, United States

AdventHealth Medical Group

Orlando, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Children's Hospital & Medical Center

Omaha, Nebraska, United States

The Children's Hospital at Montefiore

The Bronx, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Children's Medical Center

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Texas Children's Hospital - Main Hospital

Houston, Texas, United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas, United States

Seattle Children's Hospital

Seatlle, Washington, United States

West Virginia University Hospitals

Morgantown, West Virginia, United States

Cliniques Universitaires Saint-LUC UCL

Brussels, Belgium

The Hospital for Sick Children

Toronto, Canada

BC Children's Hospital

Vancouver, Canada

Prince of Wales Hospital

Shatin, Hong Kong

GCS Medical Hospital & Research Center

Ahmedabad, India

SR Kalla Memorial Gastro And General Hospital

Jaipur, India

Pratha Gastro Liver Center

Kanpur, India

Institute of Post Graduation Medical Education & Research

Kolkata, India

M. V Hospital and Research Center

Lucknow, India

Seth GS Medical College and KEM Hospital

Mumbai, India

LTMMC & LTMG Hospital

Mumbai, India

Nandita Hospital and Research Centre

Nagpur, India

Khalatkar Hospital

Nagpur, India

Midas Multispecility Hospital PVT. LTD.

Nagpur, India

All India Institute of Medical Sciences

New Delhi, India

SIDS Hospital and Research Centre

Surat, India

Samvedna Hospital

Varanasi, India

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

Bologna, Italy

Auckland Clinical Studies Limited

Auckland, New Zealand

Spitalul Grigore Alexandrescu-Sectia Pediatrie III

Bucharest, Romania

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

Bucharest, Romania

Krasnoyarsk Regional Clinical Center of Maternal and Child Welfare

Krasnoyarsk, Russia

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

Moscow, Russia

Federal Research Centre of Nutrition, Biotechnology and Food Safety

Moscow, Russia

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

Moscow, Russia

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

Saint Petersburg, Russia

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

Saint Petersburg, Russia

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

Tatarstan, Russia

Limited Medical Company Hepatolog

Tolyatti, Russia

Kyungpook National University Hospital

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Mackay Memorial Hospital

Taipei, Taiwan

Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (62)