Role of Interferon-gamma 1-b (IFN-γ) on Cells of the Innate Immune System: Functional, Biochemical and Gene Expression Studies in Patients With Chronic Granulomatous Disease

NCT ID: NCT03548818

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-16

Study Completion Date

2020-07-15

Brief Summary

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The overall goal of the study is to investigate the functional, biochemical, and gene expression effects of Interferon-gamma 1-b (IFN-γ) on the neutrophils of patients with Chronic Granulomatous Disease (CGD). The investigators hypothesize that the clinical effects demonstrated in patients with CGD treated with IFN-γ (decreased number and severity of infections) are the result of biochemical processes and upregulation of specific genes, which lead to enhanced functionality of this immune cell population.

Detailed Description

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Conditions

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Chronic Granulomatous Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Interferon Gamma-1B

Study function and biochemistry of neutrophils off the drug for one week and then 12 hours after first dose and fourth dose.

Intervention Type DRUG

Other Intervention Names

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None Noted

Eligibility Criteria

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Inclusion Criteria

* Current treatment with IFN-γ or intent to treat with this drug
* Acute infections resolved
* Subject is off treatment medications
* Women of childbearing potential must have:

* a negative urine beta-HCG, and
* be willing to practice two forms of effective contraception for the duration of study participation

Exclusion Criteria

* Pregnancy,
* Breast-feeding, or
* Unwillingness to use effective contraception
* Recent vaccination (within the last fourteen days)
* Current infection or acute health condition requiring treatment
* Chronic inflammatory complications of CGD including:

* gastric outlet or urinary tract obstruction,
* pleuritis,
* pericarditis,
* inflammatory bowel disease, or
* colitis requiring treatment.
* Un-associated chronic lung, liver, kidney, or cardiac disorders requiring active treatment
Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel R. Ambruso, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Ambruso DR, Briones NJ, Tran AD, Sanford B, Childs C, Katz BZ, Ellison M, Johnston RB, Jones KL. Interferon-gamma 1b-induced gene expression alters neutrophil function in patients with chronic granulomatous disease. PLoS One. 2025 Sep 8;20(9):e0331657. doi: 10.1371/journal.pone.0331657. eCollection 2025.

Reference Type DERIVED
PMID: 40920799 (View on PubMed)

Other Identifiers

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17-1676

Identifier Type: -

Identifier Source: org_study_id

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