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Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children
Sponsor: Assiut University
Summary
The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-11-01
Completion Date
2027-01-01
Last Updated
2025-10-09
Healthy Volunteers
No
Conditions
Interventions
Safety and efficacy of Romiplostim in Treatment of chronic ITP in children
Children diagnosed with chronic immune thrombocytopenia (ITP) will receive Romiplostim, a thrombopoietin receptor agonist administered as a once-weekly subcutaneous injection. The initial dose will be 1 µg/kg, with subsequent dose adjustments (up to a maximum of 10 µg/kg weekly) based on platelet response, in order to maintain platelet counts ≥50 × 10⁹/L while minimizing the risk of bleeding. Treatment duration will be determined according to study protocol, and patients will be monitored regularly for efficacy (platelet count response, bleeding events) and safety (adverse events, laboratory parameters).