Immune System DiseasesNCT00001406
Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia
An observational study of Immune System Diseases and Eosinophilia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Immune System Diseases, Eosinophilia, Helminthiasis
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 1997to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with marked eosinophilia, eosinophilia in tissues or suspected eosinophilic end organ involvement will be seen on this protocol. Evaluation of family members may be of interest when a genetic cause of eosinophilia in suspected in a study participant.
Who may be able to join
- 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
- Ability of subject (or Legally Authorized Representative (LAR)) to understand and sign a written informed consent document
- Eosinophilic Patients only:
- Documented peripheral blood count >1500/mm3, tissue eosinophilia (abnormal accumulation of eosinophils in the skin or other body tissues) or suspected eosinophilic end organ involvement
Show all 9Show fewer
- Primary (non-NIH) physician for routine medical care
- Relatives only:
- Extended family member of an eosinophilic participant on this protocol
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study.
- Relatives only:
- Females must not be pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Eosinophil Activation and Function in Parasitic Infections and Other Conditions With Increased Tissue or Peripheral Blood Eosinophilia in Humans
This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. They can also go up in uncommon autoimmune conditions and, rarely, in association with tumors. Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung problems, heart disease or nerve damage caused by the release of toxic substances in these cells into body tissues.
Patients 1 to 100 years of age with eosinophil counts greater than 750/ml or an abnormal accumulation of eosinophils in the skin or body tissues may be eligible for this study. All participants will have a thorough medical history, physical examination and blood tests. Depending on the person's age and symptoms, other diagnostic tests may be done, including specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a treatment study, and no experimental treatments will be offered. Patients who require treatment will receive standard medical care.
Read more
Certain other procedures may be requested solely for research purposes. All participants will be asked to donate extra blood for laboratory studies investigating how immune cells and other immune substances in the blood act to stimulate a rise in eosinophils. In addition, some participants may undergo one or more of the following:
- Annual Follow-up evaluations - Physical examinations and blood tests to evaluate changes in the patient's condition and eosinophil counts over time.
- Bone marrow biopsy and aspiration will be recommended during the initial evaluation, and in certain patients at other times when it is important to look directly at the newly developing cells in the bone marrow. For this procedure an area of skin and bone is anesthetized with xylocaine (an anesthetic similar to that used by dentists), and a very sharp needle is used to sample the bone marrow for evaluation. Bone marrow biopsy and aspiration can have side effects of pain and/or bleeding into the skin and soft tissues at the site of the procedure. Rarely the area at the biopsy site can become infected, and is treated with antibiotics.
- Genetic testing: Some of the blood drawn from you as part of this study will be used for genetic tests. Genetic tests can help researchers study how health or illness is passed on to you by your parents or from you to your children. Any genetic information collected or discovered about you or your family will be confidential.
- Leukapheresis (only patients 18 years and older) to collect large numbers of certain cells - In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm....
Read the detailed description
Study Description: This study is designed to collect data and clinical samples from participants with elevated eosinophil counts in the peripheral blood or tissues or their relatives to enhance our understanding of the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders with the ultimate goal of improving diagnostics and identifying novel treatment modalities for these patients. Eosinophilic participants will undergo an extensive clinical evaluation at baseline and at least yearly thereafter focused on the identification of the cause of eosinophilia and the presence of end organ manifestations. Blood, bone marrow, tissue, and/or body fluids will be collected for research purposes at initial and follow-up visits to address broader questions relating to the varied etiologies of eosinophilia, biomarkers of disease activity and eosinophil activation, and the functional role of eosinophils in homeostasis and disease pathogenesis. While this protocol is not primarily designed to study treatment of eosinophilic patients, the clinical and immunological responses to therapy will be monitored. This protocol will also allow clinical and laboratory evaluation of family members of subjects with eosinophilia to help identify genetic causes of eosinophilia and to provide controls for immunologic studies.
Objectives:
Primary Objective: to understand the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders
Secondary Objectives:
- To develop a diagnostic algorithm that accurately classifies eosinophilic patients by underlying etiology
- To determine the mechanisms underlying eosinophil activation and recruitment to the blood and tissues
- To understand the mechanisms of action of therapeutic agents used or in development for the treatment of HES
- To assess the signs and symptoms experienced by patients with HES
Exploratory Objectives:
- To investigate the multifunctional role of eosinophils in settings other than HES
- To understand the long-term effects of eosinophilia in patients with HES
- To assess the effects of race, sex, ethnicity, and environmental factors on the prevalence and clinical manifestations of eosinophilic disorders
Endpoints:
Primary Endpoint:
Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes (HES)
Secondary Endpoints:
- Identification of laboratory and clinical tests that distinguish between clinical and genetic variants of HES
2a. Identification of biomarkers of disease activity and specific organ involvement in eosinophilic disorders
2b. Identification of new therapeutic targets for the treatment of HES
- Delineation of the effects of therapeutic agents on eosinophil development, activation, recruitment to tissues and/or apoptosis
- Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES
Exploratory Endpoints:
- Description of the consequences of eosinophilia and/or eosinophil depletion in the context of varied immunologic and inflammatory settings
- Collection of standardized longitudinal data on disease activity and outcome in patients with hypereosinophilia.
- Comparison of prevalence and clinical manifestations of eosinophilic disorders among varied subpopulations of patients
- Keywords
- Eosinophils, Helminth Parasites, Hypereosinophilia, Allergy, Asthma, Natural History
- Medical subject headings
- Immune System Diseases, Eosinophilia, Helminthiasis, Hypersensitivity, Parasitic Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Volunteers with elevated eosinophil counts in the peripheral blood or tissues; or a relative of a volunteer with eosinophilia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders
Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes.
Measured: Ongoing assessment
Secondary outcomes (4)
To assess the signs and symptoms experienced by patients with HES
Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES
Measured: Ongoing
To understand the mechanisms of action of therapeutic agents used or in development for the treatment of HES
Delineation of the effects of therapeutic agents on eosinophil development, activation, recruitment to the tissues and/or apoptosis
Measured: Ongoing
To determine the mechanisms underlying eosinophil activation and recruitment to the blood and tissues
Identification of biomarkers of disease activity and specific organ involvement in eosinophilic disorders; identification of new therapeutic targets for the treatment of HES
Measured: Ongoing
To develop a diagnostic algorithm that accurately classifies eosinophilic patients by underlying etiology
Identification of laboratory and clinical tests that distinguish between clinical and genetic variants
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start21 Apr 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amy D Klion, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001406
- Sponsor's protocol ID
- 940079
- Other IDs
- 94-I-0079
- Status last verified
- 2 Jun 2026
- First submitted
- 3 Nov 1999
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ezekwe EAD Jr, Weskamp AL, Rahim R, Makiya MA, Wetzler L, Ware JM, Nelson C, Castillo PA, Riley CA, Brown T, Penrod L, Constantine GM, Khoury P, Boggs NA, Klion AD. Dupilumab Use in Patients With Hypereosinophilic Syndromes: A Multicenter Case Series and Review of the Literature. J Allergy Clin Immunol Pract. 2025 Jan;13(1):167-175.e6. doi: 10.1016/j.jaip.2024.10.036. Epub 2024 Nov 6.
PubMed 39515522Ezekwe EAD Jr, Khoury P, Nutman TB. Anaphylaxis. J Allergy Clin Immunol Pract. 2024 Jan;12(1):262-263.e12. doi: 10.1016/j.jaip.2023.09.028. No abstract available.
PubMed 38185496Stokes K, Yoon P, Makiya M, Gebreegziabher M, Holland-Thomas N, Ware J, Wetzler L, Khoury P, Klion AD. Mechanisms of glucocorticoid resistance in hypereosinophilic syndromes. Clin Exp Allergy. 2019 Dec;49(12):1598-1604. doi: 10.1111/cea.13509. Epub 2019 Oct 27.
PubMed 31657082Kuang FL, Legrand F, Makiya M, Ware J, Wetzler L, Brown T, Magee T, Piligian B, Yoon P, Ellis JH, Sun X, Panch SR, Powers A, Alao H, Kumar S, Quezado M, Yan L, Lee N, Kolbeck R, Newbold P, Goldman M, Fay MP, Khoury P, Maric I, Klion AD. Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome. N Engl J Med. 2019 Apr 4;380(14):1336-1346. doi: 10.1056/NEJMoa1812185.
PubMed 30943337Khoury P, Desmond R, Pabon A, Holland-Thomas N, Ware JM, Arthur DC, Kurlander R, Fay MP, Maric I, Klion AD. Clinical features predict responsiveness to imatinib in platelet-derived growth factor receptor-alpha-negative hypereosinophilic syndrome. Allergy. 2016 Jun;71(6):803-10. doi: 10.1111/all.12843. Epub 2016 Mar 2.
PubMed 26797802Khoury P, Herold J, Alpaugh A, Dinerman E, Holland-Thomas N, Stoddard J, Gurprasad S, Maric I, Simakova O, Schwartz LB, Fong J, Lee CC, Xi L, Wang Z, Raffeld M, Klion AD. Episodic angioedema with eosinophilia (Gleich syndrome) is a multilineage cell cycling disorder. Haematologica. 2015 Mar;100(3):300-7. doi: 10.3324/haematol.2013.091264. Epub 2014 Dec 19.
PubMed 25527564Khoury P, Zagallo P, Talar-Williams C, Santos CS, Dinerman E, Holland NC, Klion AD. Serum biomarkers are similar in Churg-Strauss syndrome and hypereosinophilic syndrome. Allergy. 2012 Sep;67(9):1149-56. doi: 10.1111/j.1398-9995.2012.02873.x. Epub 2012 Jul 9.
PubMed 22775568
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophil Activation and Function in Parasitic Infections and Other Conditions With Increased Tissue or Peripheral Blood Eosinophilia in Humans
- ClinicalTrials.gov ID
- NCT00001406
- Acronym / sponsor ID
- 940079
- Keywords
- Eosinophils, Helminth Parasites, Hypereosinophilia, Allergy, Asthma, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 21 Apr 1997 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. They can also go up in uncommon autoimmune conditions and, rarely, in association with tumors. Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung problems, heart disease or nerve damage caused by the release of toxic substances in these cells into body tissues.
Patients 1 to 100 years of age with eosinophil counts greater than 750/ml or an abnormal accumulation of eosinophils in the skin or body tissues may be eligible for this study. All participants will have a thorough medical history, physical examination and blood tests. Depending on the person's age and symptoms, other diagnostic tests may be done, including specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a treatment study, and no experimental treatments will be offered. Patients who require treatment will receive standard medical care.
Certain other procedures may be requested solely for research purposes. All participants will be asked to donate extra blood for laboratory studies investigating how immune cells and other immune substances in the blood act to stimulate a rise in eosinophils. In addition, some participants may undergo one or more of the following:
- Annual Follow-up evaluations - Physical examinations and blood tests to evaluate changes in the patient's condition and eosinophil counts over time.
- Bone marrow biopsy and aspiration will be recommended during the initial evaluation, and in certain patients at other times when it is important to look directly at the newly developing cells in the bone marrow. For this procedure an area of skin and bone is anesthetized with xylocaine (an anesthetic similar to that used by dentists), and a very sharp needle is used to sample the bone marrow for evaluation. Bone marrow biopsy and aspiration can have side effects of pain and/or bleeding into the skin and soft tissues at the site of the procedure. Rarely the area at the biopsy site can become infected, and is treated with antibiotics.
- Genetic testing: Some of the blood drawn from you as part of this study will be used for genetic tests. Genetic tests can help researchers study how health or illness is passed on to you by your parents or from you to your children. Any genetic information collected or discovered about you or your family will be confidential.
- Leukapheresis (only patients 18 years and older) to collect large numbers of certain cells - In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm....
Detailed description
Study Description: This study is designed to collect data and clinical samples from participants with elevated eosinophil counts in the peripheral blood or tissues or their relatives to enhance our understanding of the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders with the ultimate goal of improving diagnostics and identifying novel treatment modalities for these patients. Eosinophilic participants will undergo an extensive clinical evaluation at baseline and at least yearly thereafter focused on the identification of the cause of eosinophilia and the presence of end organ manifestations. Blood, bone marrow, tissue, and/or body fluids will be collected for research purposes at initial and follow-up visits to address broader questions relating to the varied etiologies of eosinophilia, biomarkers of disease activity and eosinophil activation, and the functional role of eosinophils in homeostasis and disease pathogenesis. While this protocol is not primarily designed to study treatment of eosinophilic patients, the clinical and immunological responses to therapy will be monitored. This protocol will also allow clinical and laboratory evaluation of family members of subjects with eosinophilia to help identify genetic causes of eosinophilia and to provide controls for immunologic studies.
Objectives:
Primary Objective: to understand the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders
Secondary Objectives:
- To develop a diagnostic algorithm that accurately classifies eosinophilic patients by underlying etiology
- To determine the mechanisms underlying eosinophil activation and recruitment to the blood and tissues
- To understand the mechanisms of action of therapeutic agents used or in development for the treatment of HES
- To assess the signs and symptoms experienced by patients with HES
Exploratory Objectives:
- To investigate the multifunctional role of eosinophils in settings other than HES
- To understand the long-term effects of eosinophilia in patients with HES
- To assess the effects of race, sex, ethnicity, and environmental factors on the prevalence and clinical manifestations of eosinophilic disorders
Endpoints:
Primary Endpoint:
Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes (HES)
Secondary Endpoints:
- Identification of laboratory and clinical tests that distinguish between clinical and genetic variants of HES
2a. Identification of biomarkers of disease activity and specific organ involvement in eosinophilic disorders
2b. Identification of new therapeutic targets for the treatment of HES
- Delineation of the effects of therapeutic agents on eosinophil development, activation, recruitment to tissues and/or apoptosis
- Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES
Exploratory Endpoints:
- Description of the consequences of eosinophilia and/or eosinophil depletion in the context of varied immunologic and inflammatory settings
- Collection of standardized longitudinal data on disease activity and outcome in patients with hypereosinophilia.
- Comparison of prevalence and clinical manifestations of eosinophilic disorders among varied subpopulations of patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Volunteers with elevated eosinophil counts in the peripheral blood or tissues; or a relative of a volunteer with eosinophilia |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with marked eosinophilia, eosinophilia in tissues or suspected eosinophilic end organ involvement will be seen on this protocol. Evaluation of family members may be of interest when a genetic cause of eosinophilia in suspected in a study participant.
Key inclusion criteria (9 listed)
- 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
- Ability of subject (or Legally Authorized Representative (LAR)) to understand and sign a written informed consent document
- Documented peripheral blood count >1500/mm3, tissue eosinophilia (abnormal accumulation of eosinophils in the skin or other body tissues) or suspected eosinophilic end organ involvement
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study.
- Females must not be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders
Time frame: Ongoing assessment
Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes.
4 secondary outcomes
To assess the signs and symptoms experienced by patients with HES
Time frame: Ongoing
To understand the mechanisms of action of therapeutic agents used or in development for the treatment of HES
Time frame: Ongoing
To determine the mechanisms underlying eosinophil activation and recruitment to the blood and tissues
Time frame: Ongoing
To develop a diagnostic algorithm that accurately classifies eosinophilic patients by underlying etiology
Time frame: Ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 39515522Ezekwe EAD Jr, Weskamp AL, Rahim R, Makiya MA, Wetzler L, Ware JM, Nelson C, Castillo PA, Riley CA, Brown T, Penrod L, Constantine GM, Khoury P, Boggs NA, Klion AD. Dupilumab Use in Patients With Hypereosinophilic Syndromes: A Multicenter Case Series and Review of the Literature. J Allergy Clin Immunol Pract. 2025 Jan;13(1):167-175.e6. doi: 10.1016/j.jaip.2024.10.036. Epub 2024 Nov 6.
- Derived from this study: PubMed 38185496Ezekwe EAD Jr, Khoury P, Nutman TB. Anaphylaxis. J Allergy Clin Immunol Pract. 2024 Jan;12(1):262-263.e12. doi: 10.1016/j.jaip.2023.09.028. No abstract available.
- Derived from this study: PubMed 31657082Stokes K, Yoon P, Makiya M, Gebreegziabher M, Holland-Thomas N, Ware J, Wetzler L, Khoury P, Klion AD. Mechanisms of glucocorticoid resistance in hypereosinophilic syndromes. Clin Exp Allergy. 2019 Dec;49(12):1598-1604. doi: 10.1111/cea.13509. Epub 2019 Oct 27.
- Derived from this study: PubMed 30943337Kuang FL, Legrand F, Makiya M, Ware J, Wetzler L, Brown T, Magee T, Piligian B, Yoon P, Ellis JH, Sun X, Panch SR, Powers A, Alao H, Kumar S, Quezado M, Yan L, Lee N, Kolbeck R, Newbold P, Goldman M, Fay MP, Khoury P, Maric I, Klion AD. Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome. N Engl J Med. 2019 Apr 4;380(14):1336-1346. doi: 10.1056/NEJMoa1812185.
- Derived from this study: PubMed 26797802Khoury P, Desmond R, Pabon A, Holland-Thomas N, Ware JM, Arthur DC, Kurlander R, Fay MP, Maric I, Klion AD. Clinical features predict responsiveness to imatinib in platelet-derived growth factor receptor-alpha-negative hypereosinophilic syndrome. Allergy. 2016 Jun;71(6):803-10. doi: 10.1111/all.12843. Epub 2016 Mar 2.
- Derived from this study: PubMed 25527564Khoury P, Herold J, Alpaugh A, Dinerman E, Holland-Thomas N, Stoddard J, Gurprasad S, Maric I, Simakova O, Schwartz LB, Fong J, Lee CC, Xi L, Wang Z, Raffeld M, Klion AD. Episodic angioedema with eosinophilia (Gleich syndrome) is a multilineage cell cycling disorder. Haematologica. 2015 Mar;100(3):300-7. doi: 10.3324/haematol.2013.091264. Epub 2014 Dec 19.
- Derived from this study: PubMed 22775568Khoury P, Zagallo P, Talar-Williams C, Santos CS, Dinerman E, Holland NC, Klion AD. Serum biomarkers are similar in Churg-Strauss syndrome and hypereosinophilic syndrome. Allergy. 2012 Sep;67(9):1149-56. doi: 10.1111/j.1398-9995.2012.02873.x. Epub 2012 Jul 9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy D Klion, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune System Diseases and Eosinophilia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori A Penrod, R.N. ((240) 627-3647, lori.penrod@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders (time frame: Ongoing assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001406, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.