Post IVIG Medication in Children With Immune Thrombocytopenia

NCT04741139 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: H-47160
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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-infusion medication for 72 hours following IVIG infusion. This year-long feasibility pilot will test the (1) feasibility of enrollment and the willingness of families to participate in a scheduled medication regimen and (2) adherence of patients and families to the scheduled medication regimen. Clinical outcomes, as defined by rates of headache or nausea/vomiting or other adverse event following IVIG, return to medical care, and need for further laboratory or imaging studies, will be collected. These rates will be compared to retrospective, historical data from Texas Children's Hematology Center from 2010 to 2019. However, due to the rate at which these events occur following IVIG, this feasibility pilot is not fully powered to detect differences in clinical outcomes.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Percentage of Eligible Patients Agreeing to Enrollment

  Patients who are considered eligible for study participation and are approached by the research team to participate will be included in the determination of enrollment feasibility.

  12 months

Secondary Outcomes (5)

• Percentage of Enrolled Patients who Achieve Medication Adherence

  12 months

• Rate of Return to Medical Care for Emergent Evaluation

  72 hours following IVIG for each patient

• Rates of IVIG-Associated Adverse Drug Events

  72 hours following IVIG for each patient

• Rate of Laboratory Evaluation with Platelet Count During Emergent Medical Evaluation

  72 hours following IVIG for each patient

• Rate of Patients Requiring Head CT During Emergent Medical Evaluation

  72 hours following IVIG for each patient

Study Arms (1)

Scheduled post-IVIG medication

EXPERIMENTAL

Utilization of post-IVIG medication with acetaminophen and diphenhydramine on a scheduled basis of 72 hours post-infusion.

Drug: Acetaminophen and Diphenhydramine Only Product

Interventions

Acetaminophen and Diphenhydramine Only Product DRUG

Using a scheduled medication regimen of diphenhydramine and acetaminophen following IVIG medication to evaluate feasibility of enrollment, medication adherence, side effects related to study medication and IVIG.

Scheduled post-IVIG medication

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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-infusion medication for 72 hours following IVIG infusion. This year-long feasibility pilot will test the (1) feasibility of enrollment and the willingness of families to participate in a scheduled medication regimen and (2) adherence of patients and families to the scheduled medication regimen. Clinical outcomes, as defined by rates of headache or nausea/vomiting or other adverse event following IVIG, return to medical care, and need for further laboratory or imaging studies, will be collected. These rates will be compared to retrospective, historical data from Texas Children's Hematology Center from 2010 to 2019. However, due to the rate at which these events occur following IVIG, this feasibility pilot is not fully powered to detect differences in clinical outcomes.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: February 5, 2021
• Study Start: September 2, 2021
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

US (1)