Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT02534350
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02534350
Study Brief:
Protocol Section:
NCT02534350