Status:
UNKNOWN
Post IVIG Medication in Children With Immune Thrombocytopenia
Lead Sponsor:
Baylor College of Medicine
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
This study is a single hospital system, single-arm year-long pilot to evaluate the feasibility of enrolling children with ITP who are receiving IVIG for treatment of disease to a scheduled post-infusi...
Detailed Description
Immune thrombocytopenia (ITP) is the most common acquired immune cytopenia in childhood, affecting 4-6 in 100,000 children. The pathophysiology of ITP is highly complex and incompletely understood. Ac...
Eligibility Criteria
Inclusion
- Diagnosis of ITP confirmed by hematology team.
- Patient receiving IVIG for a clinical indication as determined by primary hematologist. IVIG can be administered in the inpatient, outpatient, and emergency room settings.
- Age 0 to 18 years
Exclusion
- Patients with a history of anaphylaxis to IVIG infusion.
- Patients receiving IVIG for indications other than ITP.
- Patients who have previously received IVIG or who receive multiple IVIG infusions within the study period.
- Patients who require additional platelet direct therapies including corticosteroids, anti-D immunoglobulin, rituximab, or thrombopoietin receptor agonists.
- Other cause of thrombocytopenia (congenital thrombocytopenias, drug induced thrombocytopenia, bone marrow failure, liver disease, etc.) apparent by history and physical examination, and/or laboratory tests.
- Inability to tolerate oral medications
- Other medical or social factors at discretion of treating physician such as ability to follow-up, etc.
Key Trial Info
Start Date :
September 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04741139
Start Date
September 2 2021
End Date
October 1 2023
Last Update
December 27 2022
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030