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

Chronic Granulomatous Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548818
• Other study ID #: 17-1676
• Status: Completed
• Start date: May 16, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: January 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

Inclusion Criteria:

• Current treatment with IFN-? 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

Related Conditions & MeSH terms

• Chronic Granulomatous Disease
• Granuloma
• Granulomatous Disease, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Neutrophil bacterialcidal activity in patients with Chronic Granulomatous Disease (CGD) on standard treatment schedule and dose of IFN-? in comparison to results for the patients off IFN-?.	Determine changes in neutrophil function in neutrophils from patients with CGD	1 week off drug, 12 hours after a week of treatment
Primary	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-? in comparison to results for the patients off IFN-?.	Determine changes in gene expression in neutrophils from patients with CGD.	1 week off drug, 12 hours after a week of treatment
Secondary	Differences in Neutrophil biochemical studies in patients with Chronic Granulomatous Disease (CGD) on standard treatment schedule and dose of IFN-? in comparison to results for the patients off IFN-?.	Determine changes in biochemical tests in neutrophils from CGD patients.	1 week off drug, 12 hours after first dose of IFN-gamma; 12 hours after a week of treatment