New hope for kids with ITP: drug combo aims to control bleeding
NCT ID NCT07660172
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding ianalumab to eltrombopag helps children aged 5 to 17 with primary immune thrombocytopenia (ITP) who didn't improve after steroids. The goal is to see if the combination can raise platelet counts and prevent bleeding. About 36 children will take part, and the study is not yet open for enrollment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ianalumab (a biologic drug) plus eltrombopag (a pill or liquid to raise platelet counts)
- What this could lead to
- If it works, this combination could offer a new treatment option for children with ITP who don't respond to steroids, helping control bleeding risk.
- What could go wrong
- This is a small, early-phase trial with only 36 children, so results may not apply to all. The drugs may cause side effects like infections or liver issues, and the study is not yet recruiting.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Apr 2033
An estimate. End dates often move.
- Lead sponsor
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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
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Signed informed consent and/or assent must be obtained from the participant and/or their parent(s)/legal guardian(s) before any study-related activity or assessment is performed. Informed consent must be obtained from participants once they reach the local legal age of adulthood during the study. * Male or female patients aged 5 to \<18 years on the day of signing informed assent/consent (as appropriate for age). * A confirmed diagnosis of primary ITP, with insufficient response to, or relapse after a firstline corticosteroid therapy with or without IVIG. * Patients with platelet count \<30 G/L for whom eltrombopag is clinically indicated (per physician's discretion) and with no contraindications to receive eltrombopag. * Patients who are up-to-date on childhood vaccinations as per the local recommended vaccination schedule. Exclusion Criteria: * Patients with ITP who received previous second-line ITP treatments (other than corticosteroid therapy with or without IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (maximum one week) before or during screening are eligible. * Patients with key renal or hepatic laboratory abnormalities. * Patients with other hematologic diagnosis associated with cytopenias, including Evans Syndrome. * Patients with current or history of life-threatening bleeding due to thrombocytopenia. * Patients who are Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) positive. * Patients with known active or uncontrolled infections requiring systemic treatment during the screening period or history of recurrent clinically significant infection. * Patients with hepatic impairment (Child-Pugh score \>5, or equivalent). * Patients with concurrent bleeding disorders or coagulation disorders and/or receiving antiplatelet or anticoagulant medication. * Female patients who are nursing or pregnant. Other protocol-defined inclusion/exclusion may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New pill could help adults with low platelet disorder
- New drug combo aims to boost platelet counts in immune disorder
- New combo aims to boost platelets in stubborn ITP
- New hope for ITP patients: switching drugs after failed treatment
- New shot aims to boost platelets in ITP patients
- New combo therapy aims to tame rare bleeding disorder