Created at Source Raw Value Validated value
March 28, 2021, 12:31 a.m. usa

- alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) > 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available). - history of severe liver disease - stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate < 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available) - absolute neutrophil count less than 1.0 x 109 cells per l within 72 hours of randomization (the result closest to randomization should be used if several results are available) - current treatments with potent cyp3a4 inducers/inhibitors (e.g itraconazole, ketoconazole, diltiazem, verapamil, phenytoin or rifampicin) - hiv treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors* - pregnant or breast feeding. - anticipated transfer to another hospital which is not a trial site within 24 hours. - allergy to brensocatib - use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer. co-enrolment with covid-19 trials is allowed as per co-enrolment agreements and/or individual decision by the chief investigator. women of child-bearing potential must be willing to have pregnancy testing prior to trial entry. *the liverpool hiv checker (https://www.hiv-druginteractions.org/checker) should be used to check for any hiv drug interactions. simvastatin could be used as a surrogate for brensocatib as it metabolised similarly by cyp 3a4 pathway. -

- alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) > 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available). - history of severe liver disease - stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate < 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available) - absolute neutrophil count less than 1.0 x 109 cells per l within 72 hours of randomization (the result closest to randomization should be used if several results are available) - current treatments with potent cyp3a4 inducers/inhibitors (e.g itraconazole, ketoconazole, diltiazem, verapamil, phenytoin or rifampicin) - hiv treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors* - pregnant or breast feeding. - anticipated transfer to another hospital which is not a trial site within 24 hours. - allergy to brensocatib - use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer. co-enrolment with covid-19 trials is allowed as per co-enrolment agreements and/or individual decision by the chief investigator. women of child-bearing potential must be willing to have pregnancy testing prior to trial entry. *the liverpool hiv checker (https://www.hiv-druginteractions.org/checker) should be used to check for any hiv drug interactions. simvastatin could be used as a surrogate for brensocatib as it metabolised similarly by cyp 3a4 pathway. -