Active — Not RecruitingPhase 2

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

United States, Belgium, Hong Kong150 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range

2 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 decom…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 2 trial studying TAF in children and teens, what do we know so far about its safety profile in this age group, and how does that compare to what's already established in adults?
2The trial is measuring serious adverse events and general adverse events at Week 24 — based on what's been reported so far in this study, are there any side effects that would be particularly relevant for my child's age or health situation?
3The trial is no longer enrolling new participants — does that mean my child wouldn't be able to join, and if so, are there other active studies or approved treatments like tenofovir disoproxil fumarate that we should consider instead?
4The study measures whether HBV DNA drops below 20 IU/mL by Week 24, which is a short-term marker — how does that relate to long-term liver health outcomes, and is achieving that threshold a meaningful goal for my child specifically?
5Since this trial involves specific pharmacokinetic testing to understand how the drug moves through younger patients' bodies, what does that kind of monitoring involve day-to-day, and is the testing schedule realistic given our family's situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24

Timeframe: Week 24

Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24

Timeframe: Week 24

Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24

Timeframe: Week 24

PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A

Timeframe: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12

Trial details

NCT IDNCT02932150

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Chronic Hepatitis B trials

Who can participate

Age range

2 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24

Timeframe: Week 24

Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24

Timeframe: Week 24

Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24

Timeframe: Week 24

PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A

Timeframe: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12