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This study examines the functional, biochemical and gene expression effects of Interferon Gamma-1B on the cells of the innate immune system in patients with chronic granulomatous disease. It enrolled patients who were being treated or intended to be treated with this drug and whose acute infections had resolved. It was conducted as a study without a formal phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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