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Completed

NCT Number: NCT03548818

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

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.

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Key information

Conditions

Chronic Granulomatous Disease Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Genetic Diseases, X-Linked Granulomatous Disease, Chronic Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Leukocyte Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Phagocyte Bactericidal Dysfunction

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon gamma-1b

Drug

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

Other names: None Noted

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2018
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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