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New hope for kids with hepatitis b: drug trial shows promise

NCT ID NCT01651403

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an antiviral drug called tenofovir in children aged 2 to 12 with chronic hepatitis B. The goal was to see if the drug could lower the amount of virus in their blood compared to a placebo. The trial involved 90 children and measured safety and effectiveness over 48 weeks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

90 people

The number who actually took part.

Started

Dec 2012

Expected to finish

Jul 2027

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 11 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: * Male or Female, 2 to \< 12 years of age * Weight ≥ 10 kg * Chronic HBV infection ≥ 6 months * Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative * HBV Viral Load ≥ 100,000 copies/mL * Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening * Creatinine Clearance ≥ 80 mL/min/1.73m\^2 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3, hemoglobin ≥ 10 g/dL * Negative pregnancy test at screening * No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm) Key Exclusion Criteria: * Pregnant or lactating * Decompensated liver disease * Received interferon therapy within 6 months of screening * Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening * Alpha-fetoprotein levels \> 50 ng/mL * Evidence of hepatocellular carcinoma (HCC) * Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis D virus (HDV) * Chronic liver disease not due to HBV * History of significant renal, cardiovascular, pulmonary, neurological or bone disease * Long term non-steroidal, anti-inflammatory drug therapy 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

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Colors Children Hospital

    Nagpur, Maharashtra, 440012, India

  • Fundeni Clinical Institute - Constantinesco

    Bucharest, 022328, Romania

  • Grigore Alexandrescu Emergency Clinical Hospital for Children

    Bucharest, 011743, Romania

  • Kyungpook National University

    Daegu, 41944, South Korea

  • M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk

    Lucknow, Uttar Pradesh, 226003, India

  • Medanta -The Medicity

    Gurgaon, Haryana, 122 001, India

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nirmal Hospital Private Limited

    Surat, Gujarat, 395 002, India

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • SMS Medical College and Hospital

    Jaipur, Rajasthan, 302004, India

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Children's Hospital

    Seoul, 120-752, South Korea

  • St. John Hospital & Medical Center

    Bangalore, 560034, India

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology

    Craiova, 200515, Romania

More trials for these conditions

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