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

NCT02932150 Phase 2 RECRUITING

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.

Details

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	RECRUITING
Enrolment	150
Start date	2016-11
Completion	2029-10

Conditions

• Chronic Hepatitis B

Interventions

• TAF
• Placebo

Primary outcomes

• 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).

Countries

United States, Belgium, Canada, Hong Kong, India, Italy, New Zealand, Romania, Russia, South Korea, Taiwan