presatovir in lung transplant (lt) recipients with respiratory syncytial virus (rsv) infection

Conditions: Respiratory Syncytial Virus (RSV)

Summary: the primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (rsv) viral load in rsv-positive lung transplant (lt) recipients with acute respiratory symptoms.


Eligibility criteria:
key inclusion criteria: * males and females ≥18 years of age who have received a lt (single or double) or heart/lung transplant \> 90 days prior to screening * confirmed to be rsv-positive by local polymerase chain reaction (pcr) testing (starting from when the upper or lower respiratory tract sample is obtained) ≤ 7 days prior to investigational medicinal product (imp) administration on day 1/baseline * new onset or acute worsening, if the symptom is chronic, of at least 1 of the following respiratory symptoms ≤ 7 days prior to imp administration on day 1/baseline: nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or wheezing * a negative local urine or serum pregnancy test for female subjects of childbearing potential at screening, within 1 day prior to imp administration. when available, existing local pregnancy test results obtained prior to screening may be used, provided the testing was completed within 1 day prior to imp administration * agreement from male and female subjects of childbearing potential who engage in heterosexual intercourse to use protocol specified method(s) of contraception key exclusion criteria: related to concomitant or previous medication use: * use of any non-marketed (according to region) investigational agents within 30 days, or use of any investigational monoclonal anti-rsv antibodies within 4 months or 5 half-lives of screening, whichever is longer, or use of any prior investigational rsv vaccines * use of a strong or moderate cytochrome p450 enzyme (cyp) inducer including but not limited to rifampin, st. john's wort, carbamazepine, phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of imp related to transplant history: • recipient of any other organ transplant prior to screening, with the exception of a lt (single or double) or heart/lung transplant related to medical condition at screening: * known viral coinfection (including but not limited to influenza, metapneumovirus, human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or lower respiratory tract ≤ 14 days prior to screening unless discussed with the medical monitor and deemed acceptable * active systemic infection or infectious pneumonia of any etiology (ie, bacterial, viral \[other than rsv\] or fungal), including aspiration pneumonia, that is considered clinically significant by the investigator unless discussed with the medical monitor and deemed acceptable related to laboratory values: * clinically significant kidney dysfunction as defined by: an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 as calculated by the modification of diet in renal disease (mdrd) study 4 parameter equation obtained from screening laboratory measurements or via local laboratory measurements obtained ≤ 7 days prior to screening. the egfr may be manually calculated or the reported egfr value may be used, but any automatically calculated egfr must be calculated using the mdrd equation. * clinically significant liver function test abnormalities as defined by an alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 times the upper limit of normal (uln) obtained in screening laboratory measurements or via local laboratory measurements obtained ≤ 7 days prior to screening * clinically significant elevations in total bilirubin (tb), as determined by the investigator note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: respiratory syncytial virus (rsv) antiviral lung transplant