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NCT02932150

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

Active, Not Recruiting
PHASE2Ages 2–17InterventionalTreatment
Gilead Sciences
~150 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:TAFPlacebo

At a glance

Recruiting sites
0 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24
Measured over Week 24
+3 more outcomes measured

Conditions

Chronic Hepatitis B

Explore related trials

Hepatitis B InfectionHepatitis B InfectionHepatitis B Virus HBsAg Surface Protein Antigen

Where it's being run

39 sites across 17 states
India8
Taiwan5
Russia4
California3
Texas3
South Korea3
Ohio2
Romania2

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24Week 24
  • Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24Week 24
  • Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24Week 24
  • PK Parameter: AUCtau of TAF for participants from Cohort 2 Part APredose, 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).