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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 February 2021 |
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Main ID: |
NCT03548818 |
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Date of registration:
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20/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Role of Interferon-gamma 1-b (IFN-?) on Cells of the Innate Immune System: Functional, Biochemical and Gene Expression Studies in Patients With Chronic Granulomatous Disease
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Scientific title:
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Role of Interferon-gamma 1-b (IFN-?) on Cells of the Innate Immune System: Functional, Biochemical and Gene Expression Studies in Patients With Chronic Granulomatous Disease |
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Date of first enrolment:
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May 16, 2018 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03548818 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel R. Ambruso, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Granulomatous Disease
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Intervention(s)
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Drug: Interferon Gamma-1B
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Primary Outcome(s)
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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-?.
[Time Frame: 1 week off drug, 12 hours after a week of treatment]
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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-?.
[Time Frame: 1 week off drug, 12 hours after a week of treatment]
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Secondary Outcome(s)
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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-?.
[Time Frame: 1 week off drug, 12 hours after first dose of IFN-gamma; 12 hours after a week of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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