Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00091871

Conditions

Eosinophilia

Hypereosinophilic Syndrome

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Eosinophils are a type of white blood cell. Elevated eosinophil levels can damage the heart, nerves, and other organs, in the syndrome known as hypereosinophilic syndrome (HES). Some individuals have a hereditary form of HES known as familial eosinophilia (FE). More research on the causation and mechanisms of HES is needed in order to design more effective and less toxic therapies.

This study will investigate FE and its genetic causes, damage mechanisms, and disease markers (such as blood test abnormalities). It will enroll approximately 50 individuals (both adults and children) from a previously studied family with FE. This is a long-term study of indefinite duration.

Participants will undergo yearly clinical examinations including medical history, physical examination, bloodwork, EKG, echocardiogram, and pulmonary function tests, with additional or more frequent examinations and tests as required. In addition, participants will donate blood and tissue for research purposes. Both adult and child participants will donate blood. At the initial evaluation, adult participants will donate bone marrow. During the study, some adult participants will also undergo a limited number of leukaopheresis sessions, in which blood is donated from one arm, the blood is separated into red blood cells and other components, and the red blood cells are returned into the donor's other arm.

...

Conditions

Eosinophilia

Hypereosinophilic Syndrome

Study ID

NCT00091871

Start date

Jun 8, 2005

Status verified date

Apr 17, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 1-100 years of age
  • Genetically related member of a previously identified family with FE
  • Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Any condition that the investigator feels put the subject at unacceptable risk for participation in the study
  • Pregnancy (in family members who do not have eosinophilia)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Affected family members

Family members with peripheral blood eosinophilia

Unaffected family members

Family members without peripheral blood eosinophilia

Primary outcome measure

  • To study the natural history of familial hypereosinophilia (FE) [ Time Frame: 30 years ]

Central Contacts and Locations

Central contacts

Thomas W Brown, R.N.

(301) 402-7823browntw@mail.nih.gov

Amy D Klion, M.D.

(240) 381-6073amy.klion@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 1, 2026

Last verified

Apr 17, 2026

Keywords

  • Hypereosinophilia
  • Eosinophil
  • Familial
  • Interleukin 5
  • Natural History
  • Familial Hypereosinophilia
  • FE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-01.