Weekly injection could tame bleeding in kids with Hard-to-Treat ITP
NCT ID NCT07214025
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a drug called romiplostim, given as a weekly shot, in 100 children aged 1 to 18 with chronic immune thrombocytopenia (ITP) who haven't been helped by standard treatments. The goal is to see if it can safely raise platelet counts and reduce bleeding. Children will be monitored for nearly a year to check how well the drug works and if it causes any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- romiplostim (a once-weekly injection that stimulates platelet production)
- What this could lead to
- If it works, this could offer a new, effective option to control bleeding and maintain safe platelet levels in children with chronic ITP who haven't responded to standard treatments.
- What could go wrong
- This is an early-stage study with only 100 children, so results may not apply to everyone. The drug requires ongoing injections and may cause side effects like bone pain or blood clots.
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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 study will include pediatric patients aged 1 to 18 years with a diagnosis of chronic immune thrombocytopenia (ITP) who are refractory to or intolerant of first-line therapies (e.g., corticosteroids, intravenous immunoglobulin, or oral eltrombopag). Eligible patients must have a platelet count \<30,000/µL, or evidence of bleeding/risk of bleeding with platelet count \<50,000/µL. Patients with secondary or congenital thrombocytopenia, aplastic anemia, age \<1 year or \>18 years, or known hypersensitivity to romiplostim will be excluded. A total of 100 patients will be enrolled from the Pediatric Department at Assiut University Hospital.
- Ages
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Up to 18 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged between 1 and 18 years * Diagnosis of chronic ITP * Refractory to or intolerant of first-line therapies (e.g.corticosteroids , intravenous immunoglobulin \[ IVIG \] , and oral eltrombopag ) * Platelet count\<30,000/µL, or evidence of bleeding or risk of bleeding with platelet count\<50,000/µL. * Written informed consent (or parental/guardian consent for minors) Exclusion Criteria: * Evidence of secondary thrombocytopenia (e.g., HIV, HCV, systemic lupus erythematosus) * congenital thrombocytopenia * Age \< 1year or more than 18 years * Aplastic anemia * Known hypersensitivity to romiplostim or any of its components
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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
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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
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