Trials / Not Yet Recruiting
Not Yet RecruitingNCT07214025
Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Assiut University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2026-11-01
- Completion
- 2027-01-01
- First posted
- 2025-10-09
- Last updated
- 2025-10-09
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07214025. Inclusion in this directory is not an endorsement.