Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT03548818
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006105', 'term': 'Granulomatous Disease, Chronic'}], 'ancestors': [{'id': 'D010585', 'term': 'Phagocyte Bactericidal Dysfunction'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554125', 'term': 'interferon gamma-1b'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '1 week off drug, 12 hours after a week of treatment', 'description': 'Determine changes in neutrophil function in neutrophils from patients with CGD'}, {'measure': '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.', 'timeFrame': '1 week off drug, 12 hours after a week of treatment', 'description': 'Determine changes in gene expression in neutrophils from patients with CGD.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '1 week off drug, 12 hours after first dose of IFN-gamma; 12 hours after a week of treatment', 'description': 'Determine changes in biochemical tests in neutrophils from CGD patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Granulomatous Disease']}, 'referencesModule': {'references': [{'pmid': '40920799', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Investigators plan to enroll children and adults, aged 5-60 years with CGD defined by functional and biochemical or genetic testing. Enrollment will be stratified by the four main variants: X-linked, gp91phox deficient patients, and autosomal recessive CGD (p47phox deficient, p67phox deficient, and p22phox deficient patients).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current treatment with IFN-γ or intent to treat with this drug\n* Acute infections resolved\n* Subject is off treatment medications\n* Women of childbearing potential must have:\n\n * a negative urine beta-HCG, and\n * be willing to practice two forms of effective contraception for the duration of study participation\n\nExclusion Criteria:\n\n* Pregnancy,\n* Breast-feeding, or\n* Unwillingness to use effective contraception\n* Recent vaccination (within the last fourteen days)\n* Current infection or acute health condition requiring treatment\n* Chronic inflammatory complications of CGD including:\n\n * gastric outlet or urinary tract obstruction,\n * pleuritis,\n * pericarditis,\n * inflammatory bowel disease, or\n * colitis requiring treatment.\n* Un-associated chronic lung, liver, kidney, or cardiac disorders requiring active treatment'}, 'identificationModule': {'nctId': 'NCT03548818', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '17-1676'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon Gamma-1B', 'type': 'DRUG', 'otherNames': ['None Noted'], 'description': 'Study function and biochemistry of neutrophils off the drug for one week and then 12 hours after first dose and fourth dose.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Daniel R. Ambruso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}