Status:
COMPLETED
Steroid Treatment for Hypereosinophilic Syndrome
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Eosinophilia
Hypereosinophilic Syndrome
Eligibility:
All Genders
7-100 years
Phase:
PHASE4
Brief 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, nerve...
Detailed Description
This study aims to develop a model to determine whether a single, oral, weight-based dose of glucocorticoid (GC) can predict clinical and biologic response to GC s over the long term in subjects with ...
Eligibility Criteria
Inclusion
- SUBJECT INCLUSION CRITERIA:
- Subjects on Protocol #94-I-0079 will be eligible for participation in the study only if all of the following criteria apply:
- Subjects must be 7 years of age or older to enroll
- Subject meets diagnostic criteria for HES (AEC \>1500/microL, absence of a secondary cause and signs and/or symptoms attributable to the eosinophilia)
- AEC greater than 1500 microL obtained within 14 days prior to enrollment
- Willingness to perform the timed steroid challenge
- Appropriate candidate for GC treatment after challenge
- Willingness to have samples stored for future research
- SUBJECT EXCLUSION CRITERIA:
- A subject will not be eligible to participate in the study if any of the following apply:
- Receiving \>10 mg prednisone or equivalent at the time of enrollment.
- Receiving less than or equal to 10 mg of prednisone or equivalent but have not been on a fixed dose for at least 3 weeks (subjects on a current corticosteroid taper will be excluded).
- AEC less than or equal to 1500/microl on the day of the steroid challenge
- Use of immunomodulatory medications, (other than less than or equal to 10 mg/day prednisone) including but not limited to biologics, within the past 6 months.
- Pregnant at the time of screening.
- Have a known mutation in the FIP1L1-PDGFR gene.
- Any condition that, in the opinion of the investigator, places the subject at undue risk by participating in the protocol.
- Weight less than 48 kg (106 lbs) in subjects less than 18 years of age.
Exclusion
Key Trial Info
Start Date :
February 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01524536
Start Date
February 16 2012
End Date
December 10 2020
Last Update
February 15 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892