A Phase 2 Study to Conduct Preliminary Evaluations of Safety, Pharmacodynamics and Efficacy by Intravenous Administration of MR11A8 in the Treatment of Patients with Moderate to Severe Acute Respiratory Distress Syndrome(MR11A8-1).

Maruishi Pharmaceutical Co., Ltd.0 个研究点目标入组 18 人开始时间: 2014年11月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Be a male or female Japanese patient with a diagnosis of moderate or severe acute respiratory distress syndrome (ARDS) according to the Berlin definition of ARDS.
•a. Have acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
•b. Have respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload
•c. Have bilateral opacities on chest x-ray or on computer tomography scan
•d. Have hypoxaemia
•Moderate ARDS: PaO2/FIO2<=200mmHg with PEEP>=5cmH2O
•Severe ARDS: PaO2/FIO2<=100mmHg with PEEP>=5cmH2O
•2. The radiological and hypoxaemia ARDS criteria (c and d) must occur within the same 24-hour period. The time of onset of ARDS is when the last ARDS criterion is met.
•3. Patients must be administered the first dose of study medication within 48 hours of fulfilling the above inclusion criteria.
•4. Be intubated and mechanically ventilated.
•5. Have no clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates.
•6. Have provided signed written informed consent from the patient or the patient's personal legal representative.

•1. Be a woman known to be pregnant, lactating or having a positive or indeterminate pregnancy test
•2. Take part in another pharmacotherapy protocol (simultaneously)
•3. The patient is not expected to survive 24 hours.
•4. Have an underlying clinical condition (e.g. brain injury GCS<7) where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation
•5. Have severe chronic obstructive pulmonary disease requiring home oxygen or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for Continuous Positive Airway Pressure or Bilevel Positive Airway Pressure used solely for sleep-disordered breathing
•6. Have congestive heart failure, defined as New York Heart Association class IV
•7. Have acute left ventricular failure, liver failure (Child Pugh Grade C) or autoimmune hepatitis
•8. Have medical histories of hypersensitivity to component of this drug, other interferon products and biologics
•9. Be currently treated with IFN alpha or IFN beta
•10. Be receiving renal dialysis therapy for chronic renal failure
•11. Burns >=30% total body surface

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