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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predictors of Drug Resistant Epilepsy Among Pediatric Patients

NCT07241754

Epilepsy Seizure Resistance

NOT_YET_RECRUITING

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

NCT03992196

Restless Legs Syndrome

TERMINATED PHASE3

Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

NCT02225041

Intellectual Disability Perceptual Disorders Memory Disorders

COMPLETED

Efficacy of Quetiapine for Pediatric Delirium

NCT02056171

Delirium

TERMINATED PHASE1/PHASE2

Natural History Study in Pediatric Patients with STXBP1 Encephalopathy with Epilepsy

NCT05462054

STXBP1 Encephalopathy with Epilepsy

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Romiplostim N01 ITP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No