Phase 3 Study of MR11A8 in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome (ARDS)
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)
- Registration Number
- JPRN-jRCT2080223265
- Lead Sponsor
- Maruishi Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 120
(1) Japanese patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS
a) Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
b) Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS are present)
c) Radiological abnormalities on chest X-ray or on computerised tomography scan, i.e., bilateral opacities that are not fully explained by effusions, nodules, masses or lobar/lung collapse
d) Hypoxaemia
Moderate ARDS 100mmHg=5cmH2O
Severe ARDS PaO2/FiO2<=100mmHg with positive end expiratory pressure PEEP>=5cmH2O
(2) The radiological and hypoxaemia criteria in ARDS criteria (c and d) 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
(3) Administration of the first dose of study drug must be planned to take place within 48 hours of first fulfilling the above inclusion criteria
(4) Patient is intubated and mechanically ventilated
(5) A signed informed consent form from the patient or the patients personal legal representative or a professional legal representative must be available
(1) Woman known to be pregnant, lactating or with a positive or indeterminate pregnancy test
(2) Patient is simultaneously taking part in another pharmacotherapy protocol
(3) The patient is not expected to survive for 24 hours
(4) 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 neuron disease, Duchenne muscular dystrophy or rapidly progressive interstitial pulmonary fibrosis
(5) 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
(6) Patient has congestive heart failure, defined as New York Heart Association class 4
(7) Patient has acute left ventricular failure
(8) Patient has liver failure (Child-Pugh grade C)
(9) Patient has received any prior interferon (IFN)
(10) Patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients
(11) Patient is receiving renal dialysis therapy for chronic renal failure
(12) Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extracorporeal lung support
(13) Patient has had any form of mechanical ventilation (invasive or non-invasive, excluding CPAP alone) for longer than 48 hours prior to the diagnosis of ARDS. Non-invasive ventilation has to be continuously applied for at least 12 hours per day in these 48 hours
(14) Patient has burns to >_15% of their total body surface area
(15) Patient is receiving Sho-saiko-to or is scheduled to receive Sho-saiko-to during the study drug administration period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method