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Evaluating Tenofovir Alafenamide in Children and Teens with Chronic Hepatitis B

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

Phase 2 Interventional Gilead Sciences · NCT02932150

This study is testing if a new medication called tenofovir alafenamide can help children and teens with chronic hepatitis B feel better and stay safe while finding the right dose for them.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorGilead Sciences Industry-sponsored
Locations62 sites (Los Angeles, California and 61 other locations)
Trial IDNCT02932150 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the effectiveness, safety, and tolerability of tenofovir alafenamide (TAF) compared to a placebo in children and teenagers diagnosed with chronic hepatitis B virus (CHB) infection. The study will also investigate appropriate dosing levels for this age group. Participants will be monitored for their response to the treatment and any potential side effects. The trial includes various weight-based cohorts to ensure appropriate dosing and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are males and non-pregnant, non-lactating females aged 10 to 18 years with documented chronic hepatitis B infection.

Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children and teens suffering from chronic hepatitis B.

How similar studies have performed: Other studies have shown promise with similar antiviral treatments for chronic hepatitis B, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Hepatitis BCHBHBV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.