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Clinical Trials in the USA / NCT02932150
Active, not recruiting Phase 2

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

NCT02932150 · tracked via the Priya Life Science USA tracker
Sponsor
Gilead Sciences
Phase
Phase 2
Started
2016-11
Last updated
2026-06-18

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

TAFPlacebo

TAF: Administered orally once daily

Placebo: Administered orally once daily

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Children's Hospital of Los Angeles Los Angeles California
Rady Childrens Hospital San Diego California
University of California, San Francisco (UCSF) San Francisco California
Children's Hospital Colorado Aurora Colorado
Indiana University School of Medicine Indianapolis Indiana
Johns Hopkins University Baltimore Maryland
Children's Mercy Hospital Kansas City Missouri
The Children's Hospital at Montefiore The Bronx New York
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Nationwide Children's Hospital Columbus Ohio
Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville Tennessee
Cook Children's Medical Center Fort Worth Texas
Texas Children's Hospital - Main Hospital Houston Texas
American Research Corporation at Texas Liver Institute San Antonio Texas
Seattle Children's Hospital Seattle Washington
Cliniques Universitaires Saint-LUC UCL Brussels Belgium
Prince of Wales Hospital Shatin Hong Kong
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
Khalatkar Hospital Nagpur India
All India Institute of Medical Sciences New Delhi India
SIDS Hospital and Research Centre Surat India
Samvedna Hospital Varanasi India
Spitalul Grigore Alexandrescu-Sectia Pediatrie III Bucharest Romania
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" Bucharest Romania
Federal Research Centre of Nutrition, Biotechnology and Food Safety Moscow Russia
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases 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
Asan Medical Center Seoul South Korea
Samsung Medical Center 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
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Taoyuan Taiwan

More Gilead Sciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02932150 on ClinicalTrials.gov ↗ ← All trials in the USA