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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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT03548818
Collaborator
(none)
9
Enrollment
1
Location
26
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Interferon Gamma-1B

Study Design

Study Type:
Observational
Actual Enrollment :
9 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
May 16, 2018
Actual Primary Completion Date :
Jul 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Outcome Measures

Primary Outcome Measures

  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. [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. [1 week off drug, 12 hours after a week of treatment]

    Determine changes in gene expression in neutrophils from patients with CGD.

Secondary Outcome Measures

  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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 60 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Daniel R. Ambruso, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT03548818
Other Study ID Numbers:
  • 17-1676
First Posted:
Jun 7, 2018
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Granuloma
Granulomatous Disease, Chronic
Interferons
Interferon-gamma

Study Results

No Results Posted as of Jan 22, 2021