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Could a new pill help kids fight hepatitis b?

NCT ID NCT02932150

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called tenofovir alafenamide (TAF) in 150 children and teens with chronic hepatitis B. Half receive TAF and half receive a placebo for 24 weeks. Researchers are checking how safe the drug is, how the body processes it, and whether it lowers virus levels. The goal is to find a better treatment option for young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tenofovir alafenamide (TAF)
What this could lead to
If successful, this could provide a safe and effective treatment option for children with chronic hepatitis B, helping control the virus and reduce liver damage.
What could go wrong
This is an early-phase study with a small number of participants, so results may not apply to all children. The drug may not work better than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2016

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B

Contacts and locations

Locations

  • All India Institute of Medical Sciences

    New Delhi, 110029, India

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Asan Medical Center

    Seoul, 5505, South Korea

  • Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou

    Taoyuan, 33305, Taiwan

  • Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cliniques Universitaires Saint-LUC UCL

    Brussels, 1200, Belgium

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Federal Research Centre of Nutrition, Biotechnology and Food Safety

    Moscow, 115446, Russia

  • Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases

    Saint Petersburg, 197022, Russia

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Institute of Post Graduation Medical Education & Research

    Kolkata, 700020, India

  • Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"

    Bucharest, 21105, Romania

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Khalatkar Hospital

    Nagpur, 440009, India

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • LTMMC & LTMG Hospital

    Mumbai, 400022, India

  • Limited Medical Company Hepatolog

    Tolyatti, 445009, Russia

  • M. V Hospital and Research Center

    Lucknow, 226003, India

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Prince of Wales Hospital

    Shatin, Hong Kong

  • Rady Childrens Hospital

    San Diego, California, 92123, United States

  • Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov

    Tatarstan, 420110, Russia

  • SIDS Hospital and Research Centre

    Surat, 395002, India

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Samvedna Hospital

    Varanasi, 221005, India

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Seth GS Medical College and KEM Hospital

    Mumbai, 400012, India

  • Spitalul Grigore Alexandrescu-Sectia Pediatrie III

    Bucharest, 11743, Romania

  • Texas Children's Hospital - Main Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94158, United States

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Other studies related to the condition(s) this trial covers.