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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 15, 2020

Interventions

  • Drug: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Neutrophil bacterialcidal activity in patients with Chronic Granulomatous Disease (CGD) on standard treatment schedule and dose of IFN-γ in comparison to results for the patients off IFN-γ.
    • Time Frame: 1 week off drug, 12 hours after a week of treatment
    • Determine changes in neutrophil function in neutrophils from patients with CGD
  • Changes in Gene expression as measured with RNA and affimetrics gene chips in patients with Chronic Granulomatous Disease (CGD) on standard treatment schedule and dose of IFN-γ in comparison to results for the patients off IFN-γ.
    • Time Frame: 1 week off drug, 12 hours after a week of treatment
    • Determine changes in gene expression in neutrophils from patients with CGD.

Secondary Measures

  • Differences in Neutrophil biochemical studies in patients with Chronic Granulomatous Disease (CGD) on standard treatment schedule and dose of IFN-γ in comparison to results for the patients off IFN-γ.
    • Time Frame: 1 week off drug, 12 hours after first dose of IFN-gamma; 12 hours after a week of treatment
    • Determine changes in biochemical tests in neutrophils from CGD patients.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 60 Years

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel R. Ambruso, MD, Principal Investigator, University of Colorado, Denver

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