To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
Favorable overall response was defined as being alive and having a complete or partial overall response at Day 84 as determined by the DRC. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Time frame: At Day 84
Number of Participants With Favorable Overall Response
Favorable overall response was defined as having a complete or partial overall response at at any time during the 12-week treatment where the survival component was not included as a part of the response definition. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Time frame: up to 12 weeks (Day 84)
Time to Favorable Overall Response
Time to favorable overall response was defined as the time from randomization to the first favorable overall response (complete or partial response). Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Time frame: up to Day 42 or Day 84
All-cause Mortality
All-cause mortality was defined as death from any cause.
Time frame: From First Dose of Study Treatment up to Week 16 (Safety Follow-up)
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