Immune Regulation in Patients With Common Variable Immunodeficiency and Related Syndromes

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT00001244
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Immune Regulation in Patients With Common Variable Immunodeficiency and Related Syndromes
• Scientific title: Studies of Immune Regulation in Patients With Common Variable Immunodeficiency and Related Humoral Immunodeficiency Syndromes
• Date of first enrolment: January 15, 1990
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT00001244
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Kimberly L Montgomery-Recht, R.N.

• Name: Warren Strober, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

XLA

CVID

Primary Outcome(s)

Characterization of immune abnormalities [Time Frame: Ongoing]

Evaluation of organ dysfunction/damage resulting from immune abnormality [Time Frame: ongoing]

Establish pattern/pace of disease process [Time Frame: at 1 year and ongoing]

Secondary Outcome(s)

Assess ability to participate in other studies [Time Frame: ongoing]

Determine eligibility for other studies [Time Frame: ongoing]

Establish baseline of pattern/pace of disease process before participating in therapeutic trials [Time Frame: ongoing]

Secondary ID(s)

890158

89-I-0158

Source(s) of Monetary Support

Please refer to primary and secondary sponsors