Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Dist… (NCT02622724) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
Stopped: Day 90 results indicate IMP did not reduce mortality or ventilator free days
Belgium301 participantsStarted 2015-12-23
Plain-language summary
In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS:
✓. The radiological and hypoxaemia criteria (1.3 and 1.4) must be met within the same 24-hour period. The time of onset of ARDS is when the last of the two specified ARDS criteria is met
✓. Administration of the first dose of study drug must be planned to take place within 48 hours of moderate or severe ARDS diagnosis
✓. Patient is intubated and mechanically ventilated
✓. A signed informed consent form from the patient or the patient's personal legal representative or a professional legal representative must be available
✓. Patient is aged ≥18 years
Exclusion criteria
✕. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
✕. Patient is simultaneously taking part in another pharmacotherapy protocol
✕
What they're measuring
1
Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28
✕. Patient has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation, e.g., motor neurone disease, Duchenne muscular dystrophy or rapidly progressive interstitial pulmonary fibrosis
✕. Patient has severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for continuous positive airway pressure (CPAP) or bi-level positive airway pressure used solely for sleep-disordered breathing
✕. Patient has congestive heart failure, defined as New York Heart Association class IV