Search / Trial NCT00001244

Immune Regulation in Patients With Common Variable Immunodeficiency and Related Syndromes

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Trial Information

Current as of December 27, 2024

Recruiting

Keywords

Xla Natural History Humoral Immunodeficiency Cvid Agammaglobulinemia Cvid Enteropathy

ClinConnect Summary

This clinical trial is looking into the reasons why some people have common variable immunodeficiency (CVID) and related conditions. These conditions make it harder for the body to fight off infections. The researchers want to understand the underlying issues better so they can find ways to improve treatment. Patients diagnosed with CVID and their healthy family members between the ages of 18 and 85 may join the study. Eligible patients must have a confirmed diagnosis of CVID or related immune issues and be willing to provide samples for research.

Participants can expect to receive standard medical care for their condition, which may include blood tests, imaging studies, and treatments like immune globulin therapy. Some may undergo procedures to collect white blood cells or tissue samples for further testing. Family members will also provide some health information and blood samples for research purposes. All collected samples may help in developing new tests and understanding the genetic factors behind CVID. It's important for all participants to be willing to have their samples stored for future studies.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • Must have a verifiable diagnosis of common variable immune deficiency as defined by a decrease both in IgG and at least one other Ig isotype to below two standard deviations of normal control levels OR B-cell immunodeficiencies related to CVI (defined as selective IgA deficiency, hyper IgM syndrome, thymoma and agammaglobulinemia, and hypogammaglobulinemia associated with Epstein-Barr virus infection), or hypogammaglobulinemia associated with other related immunodeficiencies
  • Must be 2 years old or greater.
  • Patients with repeated infections and suspected of having an immunodeficiency syndrome.
  • Patients must have a primary medical care provider as a criterion for inclusion into this study.
  • On investigator s discretion, unaffected family members (mother, father, siblings, children, grandparents, aunts, uncles, and first cousins) may be asked for the provision of blood or buccal specimens for research purposes.
  • Patients who are lactating, may be eligible and will only undergo tests and procedures, and/or receive medications for which data exists that proves that they are minimal risk to the child.
  • Pregnant women will not be newly enrolled onto this protocol, however existing patients who become pregnant while on study will remain on study, as literature about pregnancy in CVID patients is sparse and outside providers have minimal knowledge about managing CVID during pregnancy. Pregnant women will only undergo tests and procedures, and/or receive medications for which data exists that proves that they are minimal risk to the fetus. Pregnant unaffected relatives will not be enrolled in this study).
  • All patients must be willing to have research samples stored for future studies and/or other research purposes.
  • EXCLUSION CRITERIA:
  • Presence of other medical illnesses that would preclude individuals from undergoing routine diagnostic testing or testing for immunologic features of immunodeficiency.

Trial Officials

Warren Strober, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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