Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children

Assiut University

Status: Not yet enrolling

Conditions: Romiplostim N01; ITP

Treatments: Drug: Safety and efficacy of Romiplostim in Treatment of chronic ITP in children

Study type: Observational

Funder types: Other

Identifiers

NCT07214025

Romiplostim In treatmentof ITP

Details and patient eligibility

About

The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children

Enrollment: 100 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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