Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)

StatusRecruiting
PhaseNot specified
Started

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Record History

The 50 most recent of 396 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Minor Eligibility criteria expanded, about 6 words
  3. 24 versions Re-verified since Mar 5, 2026, no change to tracked fieldsv371-v394
  4. Study Status, Eligibilityv370
  5. 23 versions Re-verified since May 2, 2025, no change to tracked fieldsv347-v369
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Hyper IgE Syndromes (HIES) are primary immunodeficiencies resulting in eczema and recurrent skin and lung infections. Autosomal dominant Hyper IgE syndrome (AD-HIIES; Job's syndrome) is caused by STAT3 mutations, and is a multi-system disorder with skeletal, vascular, and connective tissue manifestations. Understanding how STAT3 mutations cause these diverse clinical manifestations is critical to our complete understanding of bone metabolism, bronchiectasis, dental maturation, and atherosclerosis. Bi-allelic mutations in DOCK8 cause a combined immunodeficiency previously described as autosomal-recessive Hyper IgE syndrome. These individuals suffer from extensive viral infections as well as have a high incidence of malignancy and mortality. The pathogenesis of this disease and long-term natural history is being investigated. Therefore, we seek to enroll patients and families with a confirmed or suspected diagnosis of HIES syndrome for extensive phenotypic and genotypic study as well as disease management. Patients will be carefully examined by a multidisciplinary team and followed longitudinally. Through these studies we hope to better characterize the clinical presentation of STAT3-mutated HIES, DOCK8 deficiency and other causes of the hyper IgE phenotype, and to be able to identify further genetic etiologies, as well as understand the pathogenesis of HIES. We seek to enroll 300 patients and 300 relatives.
Trial Details
NCT Number NCT00006150
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Albert Einstein College of Medicine
Conditions
(from sponsor)
Infections, Pneumonia, Immune System Diseases, STAT3 Transcription Factor, Job Syndrome
Related terms Immune System Diseases, Immunologic Deficiency Syndromes, Infections, Job Syndrome, Pneumonia
Enrollment 600 participants
Start Date
Updated on ClinicalTrials.gov