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
Gilead Sciences
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
- Age range
- 2–17 years
- Sex
- All
- 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…
Interventions
- DrugTAF
Administered orally once daily
- DrugPlacebo
Administered orally once daily
Locations (62)
- Children's Hospital of Los AngelesLos Angeles, California
- Rady Childrens HospitalSan Diego, California
- University of California, San Francisco (UCSF)San Francisco, California
- Children's Hospital ColoradoAurora, Colorado
- University of Miami/Schiff Center for Liver DiseasesMiami, Florida
- AdventHealth Medical GroupOrlando, Florida