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

NCT07214025 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-10-09

No results posted yet for this study

Summary

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

Conditions

  • Romiplostim N01
  • ITP

Interventions

DRUG

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).

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-11-01
Completion
2027-01-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214025 on ClinicalTrials.gov