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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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12 December 2020 |
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Main ID: |
NCT02609932 |
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Date of registration:
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11/11/2015 |
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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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Effect of IFN-? on Innate Immune Cells
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Scientific title:
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Effect of Interferon-gamma 1-b on Innate Immune Cells |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02609932 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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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:
1. Healthy adults over the age of 18 years up to 60 years.
2. At time of screening subject is well and healthy;
3. Acute infections resolved;
4. Subject off treatment medications;
5. No diagnosis of chronic conditions or active health care issues for which the subject
is actively followed by a health care provider or is on chronic medications.
6. Non-prescription medications for mild inter-current illnesses will be allowed at the
discretion of the principal investigator.
Exclusion Criteria:
1. Pregnancy.
2. History of current infection;
3. Two weeks from most recent intercurrent infection;
4. History of recurrent infections or immunodeficiency.
Age minimum:
18 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: Administration of drug (Interferon-gamma 1-b) subcutaneously
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Primary Outcome(s)
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Change in Neutrophil Nox2 activity.
[Time Frame: Determine the change in Nox2 activity at baseline compared to results for 8,24,48,72,96 hours after each IFN dose for the SD cohort.]
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Change in Plasma IL-10 and Neuropterin concentration.
[Time Frame: Determine the change in IL-10 and neuropterin concentration at baseline compared to 4, 8, 12, 24, 36, 48, 72, and 96 hours after each IFN dose, SD cohort.]
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Change in IFN concentration and detection of anti-IFN antibody
[Time Frame: Determine the change in IFN level at baseline compared to 4, 8, 12, and 24 hours after administration of each dose of IFN-gamma in the SD cohort. Determine the change in IFN antibody at baseline compared to day 7-10 and day 30 after IFN]
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Change in Neutrophil Gene Expression Analysis.
[Time Frame: Determine the change in gene expression at baseline compared to 4, 8, 12, 24, 36, 48, 72, and 96 hours after each IFN dose, SD cohort.]
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Secondary Outcome(s)
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Change in Neutrophil Function studies.
[Time Frame: Determine the change in neutrophil function at baseline compared to results on Day 8 after the 4th dose of IFN.]
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Change in Neutrophil and Monocyte Gene Expression Analysis.
[Time Frame: Determine the change in monocyte function at baseline compared to results on Day 8 after the 4th dose of IFN.]
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Change in Anti-IFN antibody.
[Time Frame: Determine the change in IFN antibody at baseline compared to results for 7-10 da. and 30 da. after IFN.]
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Change in Monocyte function studies.
[Time Frame: Determine the change in monocyte function at baseline compared to results on Day 8 after the 4th dose of IFN.]
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Secondary ID(s)
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UL1TR001082
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15-1643
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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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