A study to assess effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) in patients having acute respiratory distress syndrome (ARDS)
- Conditions
- Adult patients diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS)MedDRA version: 20.0 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-005260-15-DE
- Lead Sponsor
- Faron Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 296
All patients must be intubated and mechanically ventilated to diagnose ARDS and be eligible for the study
1. Patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS:
1.1 Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
1.2 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 [moderate or severe ARDS] are present)
1.3 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
1.4 Hypoxaemia:
• Moderate ARDS: PaO2/FiO2 >100 mmHg (>13.3 kPa) to =200 mmHg (=26.6 kPa) with positive end expiratory pressure (PEEP) =5 cmH2O
• Severe ARDS: PaO2/FiO2 =100 mmHg (=13.3 kPa) with PEEP =5 cmH2O
2. 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
3. Administration of the first dose of study drug must be planned to take place within 48 hours of moderate or severe ARDS diagnosis
4. Patient is intubated and mechanically ventilated
5. A signed informed consent form from the patient or the patient’s personal legal representative or a professional legal representative must be available
6. Patient is aged =18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
1. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
2. Patient is simultaneously taking part in another pharmacotherapy protocol
3. 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 neurone 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 IV
7. Patient has acute left ventricular failure
8. Patient has liver failure (Child-Pugh grade C)
9. Patient has received any prior interferon
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 extra-corporeal 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 hrs per day in these 48 hours
14. Patient has burns to =15% of their total body surface area
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method