Status:
NOT_YET_RECRUITING
Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children
Lead Sponsor:
Assiut University
Conditions:
Romiplostim N01
ITP
Eligibility:
All Genders
Up to 18 years
Brief Summary
The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07214025
Start Date
November 1 2025
End Date
January 1 2027
Last Update
October 9 2025
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