Last updated on June 2017

Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)


Brief description of study

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.

Detailed Study Description

This is a Phase III clinical study to investigate the efficacy and safety of FP-1201-lyo (recombinant human interferon [IFN] beta-1a) compared to placebo in patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). Primary objective is to demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation. Currently there are no approved drugs for treating moderate or severe ARDS patients. FP-1201-lyo is a lyophilised powder form of recombinant human IFN beta-1a reconstituted in water for injection and is administered intravenously. Recombinant human IFN beta-1a is an approved treatment for patients for other indication and its safety profile in such patients is well characterised.

Clinical Study Identifier: NCT02622724

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Matti Karvonen, MD

Erasmus Hospital
Brussels, Belgium
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Matti Karvonen, MD

UZ Brussel
Brussels, Belgium
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Matti Karvonen, MD

UZ Antwerpen
Edegem, Belgium
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Matti Karvonen, MD

UZ Gent
Gent, Belgium
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Matti Karvonen, MD

Centre Hospitalier Universitaire de Li ge
Liège, Belgium
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Matti Karvonen, MD

CHU Charleroi Site H pital Civil Marie Curie
Lodelinsart, Belgium
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Matti Karvonen, MD

CHU Dinant Godinne UCL Namur
Yvoir, Belgium
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Matti Karvonen, MD

Helsinki University Hospital
Helsinki, Finland
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Matti Karvonen, MD

Kuopio University Hospital
Kuopio, Finland
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Matti Karvonen, MD

Tampere University Hospital
Tampere, Finland
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Matti Karvonen, MD

Turku University Central Hospital
Turku, Finland
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Matti Karvonen, MD

Nouvel H pital Civil
Strasbourg, France
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Matti Karvonen, MD

Centre Hospitalier R gional d'Orl ans
Orléans, France
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Matti Karvonen, MD

CHU D'Angers
Angers, France
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Matti Karvonen, MD

CHU De Poitiers
Poitiers, France
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Matti Karvonen, MD

H pital de la Croix Rousse
Lyon, France
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Matti Karvonen, MD

H pital Charles-Nicolle
Rouen, France
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Matti Karvonen, MD

CHU Cavale Blanche
Brest, France
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Matti Karvonen, MD

Centre Hospitalier Universitaire de Bic tre
Le Kremlin-Bicêtre, France
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Matti Karvonen, MD

H pital Nord Chemin des Bourrely
Marseille, France
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Matti Karvonen, MD

Piti -Salp tri re Hospital
Paris, France
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Matti Karvonen, MD

CHU Bretonneau
Tours, France
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Matti Karvonen, MD

H pital Cochin, R animation M dicale Hospitalisation
Paris, France
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Matti Karvonen, MD

Klinikum Augsburg Klinik f r An sthesiologie
Augsburg, Germany
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Matti Karvonen, MD

Charit - Universit tsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany
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Matti Karvonen, MD

Universit tsklinikum Bonn Klinik und Poliklinik f r An sthesiologie
Bonn, Germany
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Matti Karvonen, MD

Universit tsklinikum Carl Gustav Carus Klinik f r An sthesiologie und Intensivmedizin
Dresden, Germany
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Matti Karvonen, MD

Universit tsmedizin G ttingen Klinik f r An sthesiologie
Göttingen, Germany
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Matti Karvonen, MD

Universit tsklinikum Hamburg-Eppendorf Klinik f r Intesivmedizin
Hamburg, Germany
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Matti Karvonen, MD

Kliniken der Stadt K ln Klinikum Merheim
Köln, Germany
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Matti Karvonen, MD

Universit tsklinik Leipzig Klinik und Poliklinik f r An esthesiologie und Intensivtherapie
Leipzig, Germany
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Matti Karvonen, MD

Azienda Ospedaliera Universitaria Sant' Anna
Cona, Italy
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Matti Karvonen, MD

IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
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Matti Karvonen, MD

ASST Monza
Monza, Italy
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Matti Karvonen, MD

Azienda Ospedaliera Universitaria Maggiore
Novara, Italy
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Matti Karvonen, MD

Universita degli Studi di Roma "La Sapienza"
Roma, Italy
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Matti Karvonen, MD

Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
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Matti Karvonen, MD

AOU Citt della Salute e della Scienza di Torino
Torino, Italy
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Matti Karvonen, MD

Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
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Matti Karvonen, MD

Hospital Universitari Vall d'Hebron
Barcelona, Spain
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Matti Karvonen, MD

Hospital Cl nic i Provincial de Barcelona
Barcelona, Spain
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Matti Karvonen, MD

Hospital Universitario del Henares
Coslada, Spain
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Matti Karvonen, MD

Hospital Universitario de Getafe
Getafe, Spain
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Matti Karvonen, MD

Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria, Spain
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Matti Karvonen, MD

Hospital Universitari Son Espases
Palma, Spain
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Matti Karvonen, MD

Corporaci Sanit ria Parc Taul
Sabadell, Spain
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Matti Karvonen, MD

Hospital Universitari M tua de Terrassa
Terrassa, Spain
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Matti Karvonen, MD

Hospital Universitario Rio Hortega
Valladolid, Spain
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Matti Karvonen, MD

Queen Alexandra Hospital / Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
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Matti Karvonen, MD

Bristol Royal Infirmary University Hospitals, Bristol Foundation Trust
Bristol, United Kingdom
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Matti Karvonen, MD

University Hospital of Wales
Cardiff, United Kingdom
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Matti Karvonen, MD

Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
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Matti Karvonen, MD

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Hampshire, United Kingdom
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Matti Karvonen, MD

University College London Hospitals, NHS Foundation Trust
London, United Kingdom
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Matti Karvonen, MD

Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
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Matti Karvonen, MD

King's College Hospital NHS Foundation Trust
London, United Kingdom
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Matti Karvonen, MD

St George's University Hospitals, NHS Foundation Trust
London, United Kingdom
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Matti Karvonen, MD

Hammersmith Hospital Imperial College Healthcre NHS Trust
London, United Kingdom
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Matti Karvonen, MD

Charing Cross Hospital St Mary's Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
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Matti Karvonen, MD

Charing Cross Hospital Imperial College Healthcare NHS Trust
London, United Kingdom
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Matti Karvonen, MD

Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
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Matti Karvonen, MD

Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
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Matti Karvonen, MD

Lancashire Treaching Hospitals NHS Foundation Trust
Preston, United Kingdom
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