Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24 — Week 24
- Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24 — Week 24
- Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24 — Week 24
- PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A — Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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