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New study tests eltrombopag safety in kids with rare bone marrow failure

NCT ID NCT06287268

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 10 children aged 6 to 17 with aplastic anemia, a condition where the bone marrow stops making enough blood cells. The children are receiving eltrombopag (Revolade) for the first time, combined with anti-thymocyte globulin. Researchers are monitoring for serious side effects and how well the drug works, aiming to confirm its safety and effectiveness in this specific group.

What this could mean

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

Active substance
eltrombopag (Revolade)
What this could lead to
If successful, this could confirm that eltrombopag is safe and effective for treating aplastic anemia in children who haven't had prior immune-suppressing therapy.
What could go wrong
This is a small, observational study with only 10 participants, so results may not apply broadly. It is not designed to prove a cure, and risks like serious side effects are being monitored.

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.

Participants

About 10 people

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

Started

Jul 2024

Expected to finish

Oct 2028

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.

Who is studied

The survey will be conducted in pediatric patients with Aplastic anemia (AA) who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA."

Ages

6 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.

Inclusion Criteria: * Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey * Patients aged ≥ 6 years and \< 18 years at the start of treatment with eltrombopag * Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA" Exclusion Criteria: * Patients who have received ATG without concomitant use of eltrombopag * Patients with congenital AA * Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag * Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)

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Conditions

The condition(s) this trial relates to.

aplastic anemia

As listed by the trial registrant

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

Aplastic anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Nagoya, Aichi-ken, 453-8511, Japan

  • Novartis Investigative Site

    RECRUITING

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    RECRUITING

    Toyoake, Aichi-ken, 4701192, Japan

  • Novartis Investigative Site

    RECRUITING

    Chiba, Chiba, 260 8677, Japan

  • Novartis Investigative Site

    RECRUITING

    Amagasaki, Hyōgo, 660 8550, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Matsumoto, Nagano, 3908621, Japan

  • Novartis Investigative Site

    RECRUITING

    Shimajiri-Gun, Okinawa, 901-1303, Japan

  • Novartis Investigative Site

    RECRUITING

    Izumi, Osaka, 5941101, Japan

  • Novartis Investigative Site

    RECRUITING

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    RECRUITING

    Sakai, Osaka, 590-0197, Japan

  • Novartis Investigative Site

    RECRUITING

    Saitama, Saitama, 3308777, Japan

  • Novartis Investigative Site

    RECRUITING

    Ohtsu, Shiga, 5202192, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1048560, Japan

  • Novartis Investigative Site

    RECRUITING

    Ōta-ku, Tokyo, 143 8541, Japan

  • Novartis Investigative Site

    RECRUITING

    Setagaya-ku, Tokyo, 1578535, Japan

  • Novartis Investigative Site

    RECRUITING

    Wakayama, Wakayama, 641-8510, Japan

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