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

Sponsor
Assiut University
Study ID
NCT07214025
Status
Not Yet Recruiting

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Conditions

  • ITP
  • Romiplostim N01

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Safety and efficacy of Romiplostim in Treatment of chronic ITP in children — DRUG
    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).

Study Details

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

Key Dates

Start date
Nov 1, 2025
Status verified
Sep 2025
Primary completion
Nov 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Durable Platelet Response in Patients Receiving Treatment for Chronic ITP [ Time Frame: Up to 48 weeks of treatment ]

Central Contacts