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Steroid Treatment for Hypereosinophilic Syndrome

NCT01524536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-02-15

Study results available
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Summary

Background:

\- Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart, nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage. Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although most people respond to prednisone, some people develop side effects from it, or do not respond very well to treatment. Better ways of determining the dose to give could help to decide on the best therapy for HES.

Objectives:

* To determine whether a single-dose of prednisone can be used to predict which people with hypereosinophilia respond to treatment.
* To study lack of response to steroid treatment in people with HES.

Eligibility:

Inclusion criteria:

* Individuals with hypereosinophilic syndrome with high eosinophil counts.
* Individuals who are willing to have blood drawn before and after getting steroids.

Exclusion criteria:

* Individuals who are on more than 10mg of prednisone (or similar drug)
* Individuals with hypereosinophilic syndrome who are on other medications that could interfere with the study
* Women who are pregnant or breast-feeding
* Individuals who have a known gene mutation associated with chronic eosinophilic leukemia
* Children less than 18 years old who weigh less than 48kg or 106lb

Design:

* Participants will have a screening visit with a physical exam and medical history. Blood and urine samples will be collected.
* Participants will have a single dose of the steroid prednisone by mouth in the morning. Blood samples will be collected 2, 4, 24 hours after this dose.
* On the day after the steroid dose, participants will provide another blood sample in the morning.
* Participants will start to take prednisone daily when they return home. Blood samples will be collected weekly at the participant s doctor s office. The dose of prednisone will be lowered depending on the weekly eosinophil count. We will try to get each person on the lowest dose of prednisone possible that will control the disorder. Participants who do not respond or have severe side effects will be taken off prednisone. Other treatments will be considered for people who do not respond to steroids. The goal is to evaluate the response to prednisone. Our research will try to figure out why some people do not respond to steroids. Most people will complete the study within 6 to 16 weeks, depending on their response to prednisone.

Conditions

Interventions

DRUG

prednisone

Glucocorticoids (GC) are considered the first- line therapy for hypereosinophilic syndrome.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Paneez Khoury, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-16
Primary Completion
2020-12-10
Completion
2020-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01524536 on ClinicalTrials.gov